CLASS II ONGOING Device recall · Reported 15 Feb 2023 · FDA Enforcement Report

Sterile Procedural Trays, labeled as the following recalled

Medline Industries LP - Northfield is recalling Sterile Procedural Trays, labeled as the following: a. AV Shunt Cds b. Zale V-p Shunt Cds, distributed nationwide in the US. The recall was initiated on 17 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa. AV SHUNT CDS, Item Number: CDS983098D, Case UDI/GTIN: 40195327191307, Unit UDI/GTIN: 10195327191306, Lot Number: 22IBD957; b. ZALE V-P SHUNT CDS, Item Number: CDS983186J, Case UDI/GTIN: 40195327105625, Unit UDI/GTIN: 10195327105624, Lot Number: 22IBT194; c. NEURO CDS-LF, Item Number: CDS985289, Case UDI/GTIN: 40888277050502, Unit UDI/GTIN: 10888277050501, Lot Number: 22JBH363,22IBF823,22IBD861; d. MAJOR NEURO, Item Number: CDS985548N, Case UDI/GTIN: 40195327033256, Unit UDI/GTIN: 10195327033255, Lot Number: 22JBR391,22JBI641,22GBG964; e. NEURO PACK-LF, Item Number: DYNJ0038440B, Case UDI/GTIN: 40193489506885, Unit UDI/GTIN: 10193489506884, Lot Number: 22IME936; f. CUSTOM NEURO PACK-LF, Item Number: DYNJ0190156F, Case UDI/GTIN: 40193489357531, Unit UDI/GTIN: 10193489357530, Lot Number: 22JMA809; g. NEURO PACK-LF, Item Number: DYNJ0367094L, Case UDI/GTIN: 40889942123859, Unit UDI/GTIN: 10889942123858, Lot Number: 22IMI193,22HMF079; h. NEURO PACK-LF, Item Number: DYNJ0374024J, Case UDI/GTIN: 40889942902119, Unit UDI/GTIN: 10889942902118, Lot Number: 22HBW509,22HBX254,22HBV379; i. NEURO PACK-LF, Item Number: DYNJ04596K, Case UDI/GTIN: 40193489301343, Unit UDI/GTIN: 10193489301342, Lot Number: 22JMA062,22IMB264; j. NEURO PACK-LF, Item Number: DYNJ04671Q, Case UDI/GTIN: 40888277743312, Unit UDI/GTIN: 10888277743311, Lot Number: 22HMC512; k. NEURO/LAMINECTOMY BASIN PK-LF, Item Number: DYNJ0781823K, Case UDI/GTIN: 40193489919197, Unit UDI/GTIN: 10193489919196, Lot Number: 22JMB723,22HMD049; l. U H S NEURO PACK SC, Item Number: DYNJ07952J, Case UDI/GTIN: 40889942607953, Unit UDI/GTIN: 10889942607952, Lot Number: 22JBO711; m. NEURO PACK-CELEBRATION, Item Number: DYNJ14032, Case UDI/GTIN: 40080196777953, Unit UDI/GTIN: 10080196777952, Lot Number: 22KBB459,22IBU513; n. NEURO PACK, Item Number: DYNJ14077I, Case UDI/GTIN: 40193489927673, Unit UDI/GTIN: 10193489927672, Lot Number: 22JBJ480; o. NEURO BASIN PACK-LF, Item Number: DYNJ16473K, Case UDI/GTIN: 40193489920865, Unit UDI/GTIN: 10193489920864, Lot Number: 22JDC136,22HDC097; p. NEURO PACK, Item Number: DYNJ19847M, Case UDI/GTIN: 40888277792303, Unit UDI/GTIN: 10888277792302, Lot Number: 22JBY146,22JBK343; q. MAJOR NEURO PK-LF, Item Number: DYNJ21243M, Case UDI/GTIN: 40193489225236, Unit UDI/GTIN: 10193489225235, Lot Number: 22HBY346; r. NINOR NEURO PK-LF, Item Number: DYNJ21244N, Case UDI/GTIN: 40193489225229, Unit UDI/GTIN: 10193489225228, Lot Number: 22JBV649; s. NEURO VP SHUNT/VAGAL NERVE-RF, Item Number: DYNJ21925S, Case UDI/GTIN: 40195327105021, Unit UDI/GTIN: 10195327105020, Lot Number: 22IBS173; t. NEURO PACK-LF, Item Number: DYNJ25097F, Case UDI/GTIN: 40889942871576, Unit UDI/GTIN: 10889942871575, Lot Number: 22JBK228,22JBI289; u. NEURO PACK, Item Number: DYNJ30477K, Case UDI/GTIN: 40193489912679, Unit UDI/GTIN: 10193489912678, Lot Number: 22JMG210,22HMB824; v. CRANIOTOMY, Item Number: DYNJ35349C, Case UDI/GTIN: 40888277858061, Unit UDI/GTIN: 10888277858060, Lot Number: 22HBP277; w. PEDIATRIC NEURO PACK, Item Number: DYNJ35480F, Case UDI/GTIN: 40193489803694, Unit UDI/GTIN: 10193489803693, Lot Number: 22JMB626,22IMF848,22IMC064; x. NEURO MATRIX PACK, Item Number: DYNJ36594F, Case UDI/GTIN: 40193489928991, Unit UDI/GTIN: 10193489928990, Lot Number: 22JBF140,22IBG656,22HBM006; y. ACOUSTIC NEUROMA PACK-LF, Item Number: DYNJ37741B, Case UDI/GTIN: 40195327081332, Unit UDI/GTIN: 10195327081331, Lot Number: 22JMC172,22HMD563; z. MAJOR NEURO PACK-LF, Item Number: DYNJ37751B, Case UDI/GTIN: 40195327082209, Unit UDI/GTIN: 10195327082208, Lot Number: 22JMF991; aa. SCRIPPS SW NEURO PACK-LF, Item Number: DYNJ39836F, Case UDI/GTIN: 40195327176717, Unit UDI/GTIN: 10195327176716, Lot Number: 22JME760,22HMI113,22HMD278,22GMB860; bb. NEURO PACK, Item Number: DYNJ41225B, Case UDI/GTIN: 40193489675673, Unit UDI/GTIN: 10193489675672, Lot Number: 22JBX284; cc. GENERAL PACK, Item Number: DYNJ41249C, Case UDI/GTIN: 40888277882035, Unit UDI/GTIN: 10888277882034, Lot Number: 22IBG204; dd. NEURO PK, Item Number: DYNJ41276F, Case UDI/GTIN: 40195327204021, Unit UDI/GTIN: 10195327204020, Lot Number: 22JMG029,22HMD792; ee. NEURO PACK, Item Number: DYNJ41579A, Case UDI/GTIN: 40888277935274, Unit UDI/GTIN: 10888277935273, Lot Number: 22IBA883; ff. NEURO PACK, Item Number: DYNJ41633B, Case UDI/GTIN: 40888277934918, Unit UDI/GTIN: 10888277934917, Lot Number: 22IBU441,22HBX309,22HBP962; gg. NEURO PACK, Item Number: DYNJ42484, Case UDI/GTIN: 40884389924045, Unit UDI/GTIN: 10884389924044, Lot Number: 22IBH224; hh. NEURO PACK-LF, Item Number: DYNJ42844D, Case UDI/GTIN: 40193489880565, Unit UDI/GTIN: 10193489880564, Lot Number: 22JBT933,22HBZ336; ii. NEURO PACK, Item Number: DYNJ43177B, Case UDI/GTIN: 40889942884392, Unit UDI/GTIN: 10889942884391, Lot Number: 22IMC154; jj. NEURO PACK, Item Number: DYNJ43856C, Case UDI/GTIN: 40195327200238, Unit UDI/GTIN: 10195327200237, Lot Number: 22IBS432,22HBP196; kk. NEURO PACK, Item Number: DYNJ43934A, Case UDI/GTIN: 40193489733601, Unit UDI/GTIN: 10193489733600, Lot Number: 22IMD151; ll. NEURO PACK, Item Number: DYNJ44014B, Case UDI/GTIN: 40889942278917, Unit UDI/GTIN: 10889942278916, Lot Number: 22KMA329,22JMC591; mm. CRANIOTOMY PACK, Item Number: DYNJ44040, Case UDI/GTIN: 40888277085955, Unit UDI/GTIN: 10888277085954, Lot Number: 22HBV694; nn. PK, NEURO-MINOR, Item Number: DYNJ45053C, Case UDI/GTIN: 40195327248759, Unit UDI/GTIN: 10195327248758, Lot Number: 22IBT923; oo. NEURO PACK, Item Number: DYNJ45267B, Case UDI/GTIN: 40193489852425, Unit UDI/GTIN: 10193489852424, Lot Number: 22HBV288; pp. NEURO PACK, Item Number: DYNJ46232A, Case UDI/GTIN: 40889942153450, Unit UDI/GTIN: 10889942153459, Lot Number: 22JBW760; qq. NEURO PACK, Item Number: DYNJ46238C, Case UDI/GTIN: 40888277737304, Unit UDI/GTIN: 10888277737303, Lot Number: 22IBG653,22HBX977,22HBX980; rr. PK, NEURO-MINOR, Item Number: DYNJ46282A, Case UDI/GTIN: 40193489310475, Unit UDI/GTIN: 10193489310474, Lot Number: 22JBO162,22JBO223,22IBJ968; ss. NEURO BASIC, Item Number: DYNJ46424D, Case UDI/GTIN: 40193489710350, Unit UDI/GTIN: 10193489710359, Lot Number: 22IBD742; tt. NEURO BASIC, Item Number: DYNJ46424F, Case UDI/GTIN: 40195327260683, Unit UDI/GTIN: 10195327260682, Lot Number: 22JBB084; uu. CRANIOTOMY PACK (CRSJE)227-LF, Item Number: DYNJ47487A, Case UDI/GTIN: 40889942106241, Unit UDI/GTIN: 10889942106240, Lot Number: 22JMF056,22HMD080; vv. NEURO PACK, Item Number: DYNJ48765, Case UDI/GTIN: 40888277943491, Unit UDI/GTIN: 10888277943490, Lot Number: 22IBQ098,22IBE948,22HME671; ww. NEURO PACK, Item Number: DYNJ49004, Case UDI/GTIN: 40888277810809, Unit UDI/GTIN: 10888277810808, Lot Number: 22JMI090,22JMC180,22IMD860,22HMD361; xx. NEURO CRANI PACK, Item Number: DYNJ49358, Case UDI/GTIN: 40888277847096, Unit UDI/GTIN: 10888277847095, Lot Number: 22JBQ325; yy. NEURO PACK, Item Number: DYNJ49529B, Case UDI/GTIN: 40889942203780, Unit UDI/GTIN: 10889942203789, Lot Number: 22IBS439,22IBE973; zz. NEURO TRAY-LF, Item Number: DYNJ49580C, Case UDI/GTIN: 40193489231206, Unit UDI/GTIN: 10193489231205, Lot Number: 22IBN986; aaa. NEURO PACK, Item Number: DYNJ50292F, Case UDI/GTIN: 40193489834438, Unit UDI/GTIN: 10193489834437, Lot Number: 22JBV778,22JBC215; bbb. WH NEURO PACK, Item Number: DYNJ50569, Case UDI/GTIN: 40889942008453, Unit UDI/GTIN: 10889942008452, Lot Number: 22JBQ343; ccc. RFT ISC-N NEURO PACK, Item Number: DYNJ50852G, Case UDI/GTIN: 40193489565028, Unit UDI/GTIN: 10193489565027, Lot Number: 22JMA472,22HMD933; ddd. NEURO-LF, Item Number: DYNJ52055F, Case UDI/GTIN: 40195327096336, Unit UDI/GTIN: 10195327096335, Lot Number: 22IBD221; eee. NEURO PACK, Item Number: DYNJ52243B, Case UDI/GTIN: 40889942829294, Unit UDI/GTIN: 10889942829293, Lot Number: 22IMF259; fff. NEURO LUMBAR PACK, Item Number: DYNJ53664D, Case UDI/GTIN: 40193489232067, Unit UDI/GTIN: 10193489232066, Lot Number: 22IBH772; ggg. NEURO FUSION PACK-LF, Item Number: DYNJ54360C, Case UDI/GTIN: 40193489815451, Unit UDI/GTIN: 10193489815450, Lot Number: 22IBR798; hhh. NEURO CERVICAL PACK, Item Number: DYNJ55737A, Case UDI/GTIN: 40889942943266, Unit UDI/GTIN: 10889942943265, Lot Number: 22JMB645; iii. NEURO PACK, Item Number: DYNJ57663, Case UDI/GTIN: 40889942763840, Unit UDI/GTIN: 10889942763849, Lot Number: 22JBW468,22IBB120; jjj. VP SHUNT PACK, Item Number: DYNJ59702F, Case UDI/GTIN: 40195327200269, Unit UDI/GTIN: 10195327200268, Lot Number: 22JBM510; kkk. NEURO BASIC PACK, Item Number: DYNJ60054, Case UDI/GTIN: 40888277797988, Unit UDI/GTIN: 10888277797987, Lot Number: 22KBA488,22JBR179,22IBI219; lll. NEURO PACK, Item Number: DYNJ60792C, Case UDI/GTIN: 40195327126965, Unit UDI/GTIN: 10195327126964, Lot Number: 22HBN525; mmm. CHRISTUS CHILDRENS NEURO PK, Item Number: DYNJ61168B, Case UDI/GTIN: 40195327118946, Unit UDI/GTIN: 10195327118945, Lot Number: 22IBR244,22HBY116,22HBV048; nnn. CHRISTUS CHILDRENS VP SHUNT PK, Item Number: DYNJ61174B, Case UDI/GTIN: 40195327119486, Unit UDI/GTIN: 10195327119485, Lot Number: 22JLA318,22ILA429,22HLB020; ooo. RF NEURO-SHUNT PACK, Item Number: DYNJ61387A, Case UDI/GTIN: 40193489444149, Unit UDI/GTIN: 10193489444148, Lot Number: 22IMG094,22IMG100; ppp. NEURO PACK, Item Number: DYNJ61419A, Case UDI/GTIN: 40193489676366, Unit UDI/GTIN: 10193489676365, Lot Number: 22JMH617; qqq. NEURO PACK, Item Number: DYNJ61740F, Case UDI/GTIN: 40195327238811, Unit UDI/GTIN: 10195327238810, Lot Number: 22IBF063; rrr. NEURO ST DAVIDS MEDICAL CTR, Item Number: DYNJ61998, Case UDI/GTIN: 40193489615013, Unit UDI/GTIN: 10193489615012, Lot Number: 22IBF340,22HBX978,22HBX979; sss. GIO NEURO PACK, Item Number: DYNJ62652A, Case UDI/GTIN: 40193489224581, Unit UDI/GTIN: 10193489224580, Lot Number: 22IBK347; ttt. NEURO KIT, Item Number: DYNJ62854C, Case UDI/GTIN: 40193489426985, Unit UDI/GTIN: 10193489426984, Lot Number: 22IBU624; uuu. DISCECTOMY PACK, Item Number: DYNJ67835, Case UDI/GTIN: 40193489444811, Unit UDI/GTIN: 10193489444810, Lot Number: 22IBV281; vvv. NEURO PACK, Item Number: DYNJ68898C, Case UDI/GTIN: 40195327060283, Unit UDI/GTIN: 10195327060282, Lot Number: 22IMI313; www. BASIC NEURO PACK-LF, Item Number: DYNJ81867, Case UDI/GTIN: 40195327153305, Unit UDI/GTIN: 10195327153304, Lot Number: 22HMC380,22HMB884; xxx. NEURO PACK, Item Number: DYNJ82633, Case UDI/GTIN: 40195327199556, Unit UDI/GTIN: 10195327199555, Lot Number: 22HBM512; yyy. NEURO PACK, Item Number: DYNJ83029, Case UDI/GTIN: 40195327228980, Unit UDI/GTIN: 10195327228989, Lot Number: 22JBV413; zzz. NEURO, Item Number: DYNJ900904J, Case UDI/GTIN: 40193489906616, Unit UDI/GTIN: 10193489906615, Lot Number: 22JBY355,22KBC323; aaaa. NEURO, Item Number: DYNJ901680G, Case UDI/GTIN: 40193489308083, Unit UDI/GTIN: 10193489308082, Lot Number: 22KBA252,22JBE473; bbbb. FHCW NEURO PACK, Item Number: DYNJ901990C, Case UDI/GTIN: 40193489932363, Unit UDI/GTIN: 10193489932362, Lot Number: 22JBL441,22IBV599; cccc. NEURO FERREE, Item Number: DYNJ902388K, Case UDI/GTIN: 40195327224753, Unit UDI/GTIN: 10195327224752, Lot Number: 22IBS547; dddd. NEURO, Item Number: DYNJ902585A, Case UDI/GTIN: 40193489985413, Unit UDI/GTIN: 10193489985412, Lot Number: 22IDA639; eeee. NEURO PACK CW, Item Number: DYNJ903091B, Case UDI/GTIN: 40193489961530, Unit UDI/GTIN: 10193489961539, Lot Number: 22IBU575,22IBU579; ffff. NEURO, Item Number: DYNJ903519A, Case UDI/GTIN: 40889942594215, Unit UDI/GTIN: 10889942594214, Lot Number: 22JBU552; gggg. FHT NEURO, Item Number: DYNJ903566C, Case UDI/GTIN: 40193489932103, Unit UDI/GTIN: 10193489932102, Lot Number: 22JBB451; hhhh. NEURO BASIC, Item Number: DYNJ904052G, Case UDI/GTIN: 40195327220922, Unit UDI/GTIN: 10195327220921, Lot Number: 22KDA580,22KDA234; iiii. NEURO LUMBAR, Item Number: DYNJ904111I, Case UDI/GTIN: 40193489363518, Unit UDI/GTIN: 10193489363517, Lot Number: 22IBO732,22IBN438,22IBA887; jjjj. NCH NEURO, Item Number: DYNJ904797B, Case UDI/GTIN: 40195327037988, Unit UDI/GTIN: 10195327037987, Lot Number: 22IBF188; kkkk. TAVI, Item Number: DYNJ904981C, Case UDI/GTIN: 40193489475136, Unit UDI/GTIN: 10193489475135, Lot Number: 22JBV630,22JBB134; llll. CHN OR NEURO, Item Number: DYNJ907876A, Case UDI/GTIN: 40195327011117, Unit UDI/GTIN: 10195327011116, Lot Number: 22HBR766; mmmm. NEURO PACK-LF, Item Number: DYNJC9302F, Case UDI/GTIN: 40195327032754, Unit UDI/GTIN: 10195327032753, Lot Number: 22JMB483; nnnn. NEURO-CRANI-LF, Item Number: DYNJS1001A, Case UDI/GTIN: 40080196665373, Unit UDI/GTIN: 10080196665372, Lot Number: 22IBS931,22HBX420
Quantity recalled6,782 cases (15,253 units)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1088-2023
FDA event ID
91386
Recalling firm
Medline Industries LP - Northfield, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
17 Nov 2022
FDA classified
6 Feb 2023
Reported
15 Feb 2023
Type
Voluntary: Firm initiated
Reason category
Sterility

Timeline

17 Nov 2022Recall initiated by company
6 Feb 2023Classified by FDA+81 days
15 Feb 2023Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l. U H S NEURO PACK SC m. NEURO PACK-CELEBRATION n. NEURO PACK o. NEURO BASIN PACK-LF p. NEURO PACK q. MAJOR NEURO PK-LF r. NINOR NEURO PK-LF s. NEURO VP SHUNT/VAGAL NERVE-RF t. NEURO PACK-LF u. NEURO PACK v. CRANIOTOMY w. PEDIATRIC NEURO PACK x. NEURO MATRIX PACK y. ACOUSTIC NEUROMA PACK-LF z. MAJOR NEURO PACK-LF aa. SCRIPPS SW NEURO PACK-LF bb. NEURO PACK cc. GENERAL PACK dd. NEURO PK ee. NEURO PACK ff. NEURO PACK gg. NEURO PACK hh. NEURO PACK-LF ii. NEURO PACK jj. NEURO PACK kk. NEURO PACK ll. NEURO PACK mm. CRANIOTOMY PACK nn. PK, NEURO-MINOR oo. NEURO PACK pp. NEURO PACK qq. NEURO PACK rr. PK, NEURO-MINOR ss. NEURO BASIC tt. NEURO BASIC uu. CRANIOTOMY PACK (CRSJE)227-LF vv. NEURO PACK ww. NEURO PACK xx. NEURO CRANI PACK yy. NEURO PACK zz. NEURO TRAY-LF aaa. NEURO PACK bbb. WH NEURO PACK ccc. RFT ISC-N NEURO PACK ddd. NEURO-LF eee. NEURO PACK fff. NEURO LUMBAR PACK ggg. NEURO FUSION PACK-LF hhh. NEURO CERVICAL PACK iii. NEURO PACK jjj. VP SHUNT PACK kkk. NEURO BASIC PACK lll. NEURO PACK mmm. CHRISTUS CHILDRENS NEURO PK nnn. CHRISTUS CHILDRENS VP SHUNT PK ooo. RF NEURO-SHUNT PACK ppp. NEURO PACK qqq. NEURO PACK rrr. NEURO ST DAVIDS MEDICAL CTR sss. GIO NEURO PACK ttt. NEURO KIT uuu. DISCECTOMY PACK vvv. NEURO PACK www. BASIC NEURO PACK-LF xxx. NEURO PACK yyy. NEURO PACK zzz. NEURO aaaa. NEURO bbbb. FHCW NEURO PACK cccc. NEURO FERREE dddd. NEURO eeee. NEURO PACK CW ffff. NEURO gggg. FHT NEURO hhhh. NEURO BASIC iiii. NEURO LUMBAR jjjj. NCH NEURO kkkk. TAVI llll. CHN OR NEURO mmmm. NEURO PACK-LF nnnn. NEURO-CRANI-LF

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Nationwide

Questions about this recall

Why was it recalled?

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Which lots are affected?

a. AV SHUNT CDS, Item Number: CDS983098D, Case UDI/GTIN: 40195327191307, Unit UDI/GTIN: 10195327191306, Lot Number: 22IBD957; b. ZALE V-P SHUNT CDS, Item Number: CDS983186J, Case UDI/GTIN: 40195327105625, Unit UDI/GTIN: 10195327105624, Lot Number: 22IBT194; c. NEURO CDS-LF, Item Number: CDS985289, Case UDI/GTIN: 40888277050502, Unit UDI/GTIN: 10888277050501, Lot Number: 22JBH363,22IBF823,22IBD861; d. MAJOR NEURO, Item Number: CDS985548N, Case UDI/GTIN: 40195327033256, Unit UDI/GTIN: 10195327033255, Lot Number: 22JBR391,22JBI641,22GBG964; e. NEURO PACK-LF, Item Number: DYNJ0038440B, Case UDI/GTIN: 40193489506885, Unit UDI/GTIN: 10193489506884, Lot Number: 22IME936; f. CUSTOM NEURO PACK-LF, Item Number: DYNJ0190156F, Case UDI/GTIN: 40193489357531, Unit UDI/GTIN: 10193489357530, Lot Number: 22JMA809; g. NEURO PACK-LF, Item Number: DYNJ0367094L, Case UDI/GTIN: 40889942123859, Unit UDI/GTIN: 10889942123858, Lot Number: 22IMI193,22HMF079; h. NEURO PACK-LF, Item Number: DYNJ0374024J, Case UDI/GTIN: 40889942902119, Unit UDI/GTIN: 10889942902118, Lot Number: 22HBW509,22HBX254,22HBV379; i. NEURO PACK-LF, Item Number: DYNJ04596K, Case UDI/GTIN: 40193489301343, Unit UDI/GTIN: 10193489301342, Lot Number: 22JMA062,22IMB264; j. NEURO PACK-LF, Item Number: DYNJ04671Q, Case UDI/GTIN: 40888277743312, Unit UDI/GTIN: 10888277743311, Lot Number: 22HMC512; k. NEURO/LAMINECTOMY BASIN PK-LF, Item Number: DYNJ0781823K, Case UDI/GTIN: 40193489919197, Unit UDI/GTIN: 10193489919196, Lot Number: 22JMB723,22HMD049; l. U H S NEURO PACK SC, Item Number: DYNJ07952J, Case UDI/GTIN: 40889942607953, Unit UDI/GTIN: 10889942607952, Lot Number: 22JBO711; m. NEURO PACK-CELEBRATION, Item Number: DYNJ14032, Case UDI/GTIN: 40080196777953, Unit UDI/GTIN: 10080196777952, Lot Number: 22KBB459,22IBU513; n. NEURO PACK, Item Number: DYNJ14077I, Case UDI/GTIN: 40193489927673, Unit UDI/GTIN: 10193489927672, Lot Number: 22JBJ480; o. NEURO BASIN PACK-LF, Item Number: DYNJ16473K, Case UDI/GTIN: 40193489920865, Unit UDI/GTIN: 10193489920864, Lot Number: 22JDC136,22HDC097; p. NEURO PACK, Item Number: DYNJ19847M, Case UDI/GTIN: 40888277792303, Unit UDI/GTIN: 10888277792302, Lot Number: 22JBY146,22JBK343; q. MAJOR NEURO PK-LF, Item Number: DYNJ21243M, Case UDI/GTIN: 40193489225236, Unit UDI/GTIN: 10193489225235, Lot Number: 22HBY346; r. NINOR NEURO PK-LF, Item Number: DYNJ21244N, Case UDI/GTIN: 40193489225229, Unit UDI/GTIN: 10193489225228, Lot Number: 22JBV649; s. NEURO VP SHUNT/VAGAL NERVE-RF, Item Number: DYNJ21925S, Case UDI/GTIN: 40195327105021, Unit UDI/GTIN: 10195327105020, Lot Number: 22IBS173; t. NEURO PACK-LF, Item Number: DYNJ25097F, Case UDI/GTIN: 40889942871576, Unit UDI/GTIN: 10889942871575, Lot Number: 22JBK228,22JBI289; u. NEURO PACK, Item Number: DYNJ30477K, Case UDI/GTIN: 40193489912679, Unit UDI/GTIN: 10193489912678, Lot Number: 22JMG210,22HMB824; v. CRANIOTOMY, Item Number: DYNJ35349C, Case UDI/GTIN: 40888277858061, Unit UDI/GTIN: 10888277858060, Lot Number: 22HBP277; w. PEDIATRIC NEURO PACK, Item Number: DYNJ35480F, Case UDI/GTIN: 40193489803694, Unit UDI/GTIN: 10193489803693, Lot Number: 22JMB626,22IMF848,22IMC064; x. NEURO MATRIX PACK, Item Number: DYNJ36594F, Case UDI/GTIN: 40193489928991, Unit UDI/GTIN: 10193489928990, Lot Number: 22JBF140,22IBG656,22HBM006; y. ACOUSTIC NEUROMA PACK-LF, Item Number: DYNJ37741B, Case UDI/GTIN: 40195327081332, Unit UDI/GTIN: 10195327081331, Lot Number: 22JMC172,22HMD563; z. MAJOR NEURO PACK-LF, Item Number: DYNJ37751B, Case UDI/GTIN: 40195327082209, Unit UDI/GTIN: 10195327082208, Lot Number: 22JMF991; aa. SCRIPPS SW NEURO PACK-LF, Item Number: DYNJ39836F, Case UDI/GTIN: 40195327176717, Unit UDI/GTIN: 10195327176716, Lot Number: 22JME760,22HMI113,22HMD278,22GMB860; bb. NEURO PACK, Item Number: DYNJ41225B, Case UDI/GTIN: 40193489675673, Unit UDI/GTIN: 10193489675672, Lot Number: 22JBX284; cc. GENERAL PACK, Item Number: DYNJ41249C, Case UDI/GTIN: 40888277882035, Unit UDI/GTIN: 10888277882034, Lot Number: 22IBG204; dd. NEURO PK, Item Number: DYNJ41276F, Case UDI/GTIN: 40195327204021, Unit UDI/GTIN: 10195327204020, Lot Number: 22JMG029,22HMD792; ee. NEURO PACK, Item Number: DYNJ41579A, Case UDI/GTIN: 40888277935274, Unit UDI/GTIN: 10888277935273, Lot Number: 22IBA883; ff. NEURO PACK, Item Number: DYNJ41633B, Case UDI/GTIN: 40888277934918, Unit UDI/GTIN: 10888277934917, Lot Number: 22IBU441,22HBX309,22HBP962; gg. NEURO PACK, Item Number: DYNJ42484, Case UDI/GTIN: 40884389924045, Unit UDI/GTIN: 10884389924044, Lot Number: 22IBH224; hh. NEURO PACK-LF, Item Number: DYNJ42844D, Case UDI/GTIN: 40193489880565, Unit UDI/GTIN: 10193489880564, Lot Number: 22JBT933,22HBZ336; ii. NEURO PACK, Item Number: DYNJ43177B, Case UDI/GTIN: 40889942884392, Unit UDI/GTIN: 10889942884391, Lot Number: 22IMC154; jj. NEURO PACK, Item Number: DYNJ43856C, Case UDI/GTIN: 40195327200238, Unit UDI/GTIN: 10195327200237, Lot Number: 22IBS432,22HBP196; kk. NEURO PACK, Item Number: DYNJ43934A, Case UDI/GTIN: 40193489733601, Unit UDI/GTIN: 10193489733600, Lot Number: 22IMD151; ll. NEURO PACK, Item Number: DYNJ44014B, Case UDI/GTIN: 40889942278917, Unit UDI/GTIN: 10889942278916, Lot Number: 22KMA329,22JMC591; mm. CRANIOTOMY PACK, Item Number: DYNJ44040, Case UDI/GTIN: 40888277085955, Unit UDI/GTIN: 10888277085954, Lot Number: 22HBV694; nn. PK, NEURO-MINOR, Item Number: DYNJ45053C, Case UDI/GTIN: 40195327248759, Unit UDI/GTIN: 10195327248758, Lot Number: 22IBT923; oo. NEURO PACK, Item Number: DYNJ45267B, Case UDI/GTIN: 40193489852425, Unit UDI/GTIN: 10193489852424, Lot Number: 22HBV288; pp. NEURO PACK, Item Number: DYNJ46232A, Case UDI/GTIN: 40889942153450, Unit UDI/GTIN: 10889942153459, Lot Number: 22JBW760; qq. NEURO PACK, Item Number: DYNJ46238C, Case UDI/GTIN: 40888277737304, Unit UDI/GTIN: 10888277737303, Lot Number: 22IBG653,22HBX977,22HBX980; rr. PK, NEURO-MINOR, Item Number: DYNJ46282A, Case UDI/GTIN: 40193489310475, Unit UDI/GTIN: 10193489310474, Lot Number: 22JBO162,22JBO223,22IBJ968; ss. NEURO BASIC, Item Number: DYNJ46424D, Case UDI/GTIN: 40193489710350, Unit UDI/GTIN: 10193489710359, Lot Number: 22IBD742; tt. NEURO BASIC, Item Number: DYNJ46424F, Case UDI/GTIN: 40195327260683, Unit UDI/GTIN: 10195327260682, Lot Number: 22JBB084; uu. CRANIOTOMY PACK (CRSJE)227-LF, Item Number: DYNJ47487A, Case UDI/GTIN: 40889942106241, Unit UDI/GTIN: 10889942106240, Lot Number: 22JMF056,22HMD080; vv. NEURO PACK, Item Number: DYNJ48765, Case UDI/GTIN: 40888277943491, Unit UDI/GTIN: 10888277943490, Lot Number: 22IBQ098,22IBE948,22HME671; ww. NEURO PACK, Item Number: DYNJ49004, Case UDI/GTIN: 40888277810809, Unit UDI/GTIN: 10888277810808, Lot Number: 22JMI090,22JMC180,22IMD860,22HMD361; xx. NEURO CRANI PACK, Item Number: DYNJ49358, Case UDI/GTIN: 40888277847096, Unit UDI/GTIN: 10888277847095, Lot Number: 22JBQ325; yy. NEURO PACK, Item Number: DYNJ49529B, Case UDI/GTIN: 40889942203780, Unit UDI/GTIN: 10889942203789, Lot Number: 22IBS439,22IBE973; zz. NEURO TRAY-LF, Item Number: DYNJ49580C, Case UDI/GTIN: 40193489231206, Unit UDI/GTIN: 10193489231205, Lot Number: 22IBN986; aaa. NEURO PACK, Item Number: DYNJ50292F, Case UDI/GTIN: 40193489834438, Unit UDI/GTIN: 10193489834437, Lot Number: 22JBV778,22JBC215; bbb. WH NEURO PACK, Item Number: DYNJ50569, Case UDI/GTIN: 40889942008453, Unit UDI/GTIN: 10889942008452, Lot Number: 22JBQ343; ccc. RFT ISC-N NEURO PACK, Item Number: DYNJ50852G, Case UDI/GTIN: 40193489565028, Unit UDI/GTIN: 10193489565027, Lot Number: 22JMA472,22HMD933; ddd. NEURO-LF, Item Number: DYNJ52055F, Case UDI/GTIN: 40195327096336, Unit UDI/GTIN: 10195327096335, Lot Number: 22IBD221; eee. NEURO PACK, Item Number: DYNJ52243B, Case UDI/GTIN: 40889942829294, Unit UDI/GTIN: 10889942829293, Lot Number: 22IMF259; fff. NEURO LUMBAR PACK, Item Number: DYNJ53664D, Case UDI/GTIN: 40193489232067, Unit UDI/GTIN: 10193489232066, Lot Number: 22IBH772; ggg. NEURO FUSION PACK-LF, Item Number: DYNJ54360C, Case UDI/GTIN: 40193489815451, Unit UDI/GTIN: 10193489815450, Lot Number: 22IBR798; hhh. NEURO CERVICAL PACK, Item Number: DYNJ55737A, Case UDI/GTIN: 40889942943266, Unit UDI/GTIN: 10889942943265, Lot Number: 22JMB645; iii. NEURO PACK, Item Number: DYNJ57663, Case UDI/GTIN: 40889942763840, Unit UDI/GTIN: 10889942763849, Lot Number: 22JBW468,22IBB120; jjj. VP SHUNT PACK, Item Number: DYNJ59702F, Case UDI/GTIN: 40195327200269, Unit UDI/GTIN: 10195327200268, Lot Number: 22JBM510; kkk. NEURO BASIC PACK, Item Number: DYNJ60054, Case UDI/GTIN: 40888277797988, Unit UDI/GTIN: 10888277797987, Lot Number: 22KBA488,22JBR179,22IBI219; lll. NEURO PACK, Item Number: DYNJ60792C, Case UDI/GTIN: 40195327126965, Unit UDI/GTIN: 10195327126964, Lot Number: 22HBN525; mmm. CHRISTUS CHILDRENS NEURO PK, Item Number: DYNJ61168B, Case UDI/GTIN: 40195327118946, Unit UDI/GTIN: 10195327118945, Lot Number: 22IBR244,22HBY116,22HBV048; nnn. CHRISTUS CHILDRENS VP SHUNT PK, Item Number: DYNJ61174B, Case UDI/GTIN: 40195327119486, Unit UDI/GTIN: 10195327119485, Lot Number: 22JLA318,22ILA429,22HLB020; ooo. RF NEURO-SHUNT PACK, Item Number: DYNJ61387A, Case UDI/GTIN: 40193489444149, Unit UDI/GTIN: 10193489444148, Lot Number: 22IMG094,22IMG100; ppp. NEURO PACK, Item Number: DYNJ61419A, Case UDI/GTIN: 40193489676366, Unit UDI/GTIN: 10193489676365, Lot Number: 22JMH617; qqq. NEURO PACK, Item Number: DYNJ61740F, Case UDI/GTIN: 40195327238811, Unit UDI/GTIN: 10195327238810, Lot Number: 22IBF063; rrr. NEURO ST DAVIDS MEDICAL CTR, Item Number: DYNJ61998, Case UDI/GTIN: 40193489615013, Unit UDI/GTIN: 10193489615012, Lot Number: 22IBF340,22HBX978,22HBX979; sss. GIO NEURO PACK, Item Number: DYNJ62652A, Case UDI/GTIN: 40193489224581, Unit UDI/GTIN: 10193489224580, Lot Number: 22IBK347; ttt. NEURO KIT, Item Number: DYNJ62854C, Case UDI/GTIN: 40193489426985, Unit UDI/GTIN: 10193489426984, Lot Number: 22IBU624; uuu. DISCECTOMY PACK, Item Number: DYNJ67835, Case UDI/GTIN: 40193489444811, Unit UDI/GTIN: 10193489444810, Lot Number: 22IBV281; vvv. NEURO PACK, Item Number: DYNJ68898C, Case UDI/GTIN: 40195327060283, Unit UDI/GTIN: 10195327060282, Lot Number: 22IMI313; www. BASIC NEURO PACK-LF, Item Number: DYNJ81867, Case UDI/GTIN: 40195327153305, Unit UDI/GTIN: 10195327153304, Lot Number: 22HMC380,22HMB884; xxx. NEURO PACK, Item Number: DYNJ82633, Case UDI/GTIN: 40195327199556, Unit UDI/GTIN: 10195327199555, Lot Number: 22HBM512; yyy. NEURO PACK, Item Number: DYNJ83029, Case UDI/GTIN: 40195327228980, Unit UDI/GTIN: 10195327228989, Lot Number: 22JBV413; zzz. NEURO, Item Number: DYNJ900904J, Case UDI/GTIN: 40193489906616, Unit UDI/GTIN: 10193489906615, Lot Number: 22JBY355,22KBC323; aaaa. NEURO, Item Number: DYNJ901680G, Case UDI/GTIN: 40193489308083, Unit UDI/GTIN: 10193489308082, Lot Number: 22KBA252,22JBE473; bbbb. FHCW NEURO PACK, Item Number: DYNJ901990C, Case UDI/GTIN: 40193489932363, Unit UDI/GTIN: 10193489932362, Lot Number: 22JBL441,22IBV599; cccc. NEURO FERREE, Item Number: DYNJ902388K, Case UDI/GTIN: 40195327224753, Unit UDI/GTIN: 10195327224752, Lot Number: 22IBS547; dddd. NEURO, Item Number: DYNJ902585A, Case UDI/GTIN: 40193489985413, Unit UDI/GTIN: 10193489985412, Lot Number: 22IDA639; eeee. NEURO PACK CW, Item Number: DYNJ903091B, Case UDI/GTIN: 40193489961530, Unit UDI/GTIN: 10193489961539, Lot Number: 22IBU575,22IBU579; ffff. NEURO, Item Number: DYNJ903519A, Case UDI/GTIN: 40889942594215, Unit UDI/GTIN: 10889942594214, Lot Number: 22JBU552; gggg. FHT NEURO, Item Number: DYNJ903566C, Case UDI/GTIN: 40193489932103, Unit UDI/GTIN: 10193489932102, Lot Number: 22JBB451; hhhh. NEURO BASIC, Item Number: DYNJ904052G, Case UDI/GTIN: 40195327220922, Unit UDI/GTIN: 10195327220921, Lot Number: 22KDA580,22KDA234; iiii. NEURO LUMBAR, Item Number: DYNJ904111I, Case UDI/GTIN: 40193489363518, Unit UDI/GTIN: 10193489363517, Lot Number: 22IBO732,22IBN438,22IBA887; jjjj. NCH NEURO, Item Number: DYNJ904797B, Case UDI/GTIN: 40195327037988, Unit UDI/GTIN: 10195327037987, Lot Number: 22IBF188; kkkk. TAVI, Item Number: DYNJ904981C, Case UDI/GTIN: 40193489475136, Unit UDI/GTIN: 10193489475135, Lot Number: 22JBV630,22JBB134; llll. CHN OR NEURO, Item Number: DYNJ907876A, Case UDI/GTIN: 40195327011117, Unit UDI/GTIN: 10195327011116, Lot Number: 22HBR766; mmmm. NEURO PACK-LF, Item Number: DYNJC9302F, Case UDI/GTIN: 40195327032754, Unit UDI/GTIN: 10195327032753, Lot Number: 22JMB483; nnnn. NEURO-CRANI-LF, Item Number: DYNJS1001A, Case UDI/GTIN: 40080196665373, Unit UDI/GTIN: 10080196665372, Lot Number: 22IBS931,22HBX420

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

34 other products · FDA event 91386

This product is part of a recall event; the main page for the event is Sterile Procedural Trays, labeled as the following recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IIUniversal Core Dr Runnels Pack recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IILocal Pack. Sterile Procedural Tray recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IIFemoral Artery Pack-lf recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Tray, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following: LS MS PACK recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IITrach Pack. Sterile Procedural Tray recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IIAncillary Pack-lf recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following: IM NAIL recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISterile Procedural Trays, labeled as the following recalledMedline Industries LP - NorthfieldSterilityNationwide

More recalls from Medline Industries LP - Northfield

All 792

Other Other Medical Devices recalls

All 13,778