CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report
Custom Sterile and Non-Sterile Procedural Kits recalled
Medline Industries LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel, distributed nationwide in the US. The recall was initiated on 15 May 2023 and the FDA has classified it as Class II.
Check your package
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-2299-2023
- FDA event ID
- 92399
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 May 2023
- FDA classified
- 3 Aug 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 15 May 2023 | Recall initiated by company | |
| 3 Aug 2023 | Classified by FDA | +80 days |
| 9 Aug 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935; j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US; k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670; l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090; m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930; n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US; o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I; p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010; q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615; r. OR ANGIO PACK, Model Number: DYNJ59184B; s. OR ANGIOGRAM, Model Number: DYNJ909267; t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D; u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B; v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D; w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665; x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A; y. PACK CARDIAC CATH, Model Number: DYNJ65481; z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B; aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I; bb. PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K; cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C; dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D; ee. PERMA CATH PACK, Model Number: DYNJ62007A; ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665; gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190; hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380; ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655; jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650; kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660; ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685; mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F; nn. PK, RADIOLOGY, Model Number: DYNJ43894B; oo. PORT A CATH PACK, Model Number: DYNJ59307F; pp. PORT PACK, Model Number: DYNJ58162; qq. PORTACATH PACK, Model Number: DYNJ51240A; rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700; ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995; tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135; uu. QUAD LUMEN KIT, Model Number: ECVC5820; vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913; ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C; xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000; yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B; zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835; aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030; bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041; ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729; ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G; eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C; fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R; ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C; hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A; iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A; jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Questions about this recall
Why was it recalled?
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Which lots are affected?
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ECVC475, UPC Number: 10653160333081. b. Model Number: ECVC3900, UPC Number: 10653160334828. c. Model Number: STCVC20US, UPC Number: 10653160339076. d. Model Number: STCVC21US, UPC Number: 10653160339045. e. Model Number: ECVC6585A, UPC Number: 10653160338826. f. Model Number: ECVC7235A, UPC Number: 10653160354550. g. Model Number: STCVC03US, UPC Number: 10653160339212. h. Model Number: ECVC6655A, UPC Number:10653160339267. i. Model Number: ECVC7935, UPC Number: 10653160353669. j. Model Number: STCVC04US, UPC Number: 10653160339199. k. Model Number: ECVC7670, UPC Number:10653160348054. l. Model Number: ECVC7090, UPC Number: 10653160339243. m. Model Number: ECVC6930, UPC Number:10653160339250. n. Model Number: STCVC13US, UPC Number: 10653160339137. o. Model Number: DYNJ47646D, UPC Number: 019348995047; Model Number: DYNJ47646F, UPC Number: 019532715551; Model Number: DYNJ47646G, UPC Number: 019532717502; Model Number: DYNJ47646I, UPC Number: 019532735712. p. Model Number: ECVC8010, UPC Number: 10653160356356. q. Model Number: ECVC4615, UPC Number: 10653160336075. r. Model Number: DYNJ59184B, UPC Number: 019348994910. s. Model Number: DYNJ909267, UPC Number: 019532731461. t. Model Number: DYNJ906297D, UPC Number: 019532714128. u. Model Number: DYNJ67245A, UPC Number: 019532702425; Model Number: DYNJ67245B, UPC Number: 019532729222. v. Model Number: DYNJ63372A, UPC Number: 019348929205; Model Number: DYNJ63372B, UPC Number: 019348947044; Model Number: DYNJ63372C, UPC Number: 019532708614; Model Number: DYNJ63372D, UPC Number: 019532727047. w. Model Number: ECVC6665, UPC Number: 10653160337843. x. Model Number: DYNJ69763, UPC Number: 019348997737; Model Number: DYNJ69763A, UPC Number: 019532733001. y. Model Number: DYNJ65481, UPC Number: 019348928046. z. Model Number: DYNJ60112B, UPC Number: 019532711884. aa. Model Number: DYNJ54755G, UPC Number: 019348998776; Model Number: DYNJ54755I, UPC Number: 019532702126. bb. Model Number: DYNJ0843244K, UPC Number: 019532728859. cc. Model Number: DYNJ57645C, UPC Number:019532728741. dd. Model Number: DYNJ46035C, UPC Number: 019348934095; Model Number: DYNJ46035D, UPC Number: 019348949364. ee. Model Number: DYNJ62007A, UPC Number: 019348987890. ff. Model Number: ECVC3665, UPC Number: 10653160336044. gg. Model Number: ECVC6190, UPC Number: 10653160337751. hh. Model Number: ECVC4380, UPC Number: 10653160338147. ii. Model Number: ECVC5655, UPC Number: 10653160337621. jj. Model Number: ECVC5650, UPC Number: 10653160336457. kk. Model Number: ECVC5660, UPC Number: 10653160337638. ll. Model Number: ECVC5685, UPC Number: 10653160337652. mm. Model Number: DYNJ0275614F, UPC Number: 088994217434. nn. Model Number: DYNJ43894B, UPC Number: 019348981048. oo. Model Number: DYNJ59307F, UPC Number: 019532705885. pp. Model Number: DYNJ58162, UPC Number: 088994282933. qq. Model Number: DYNJ51240A, UPC Number: 088994249352. rr. Model Number: ECVC3700, UPC Number: 10653160332886. ss. Model Number: ECVC4995, UPC Number: 10653160335283. tt. Model Number: ECVC5025, UPC Number: 10653160333142; Model Number: ECVC4135, UPC Number: 10653160335900. uu. Model Number: ECVC5820, UPC Number: 10653160338123. vv. Model Number: DYNJ65913, UPC Number: 019348930317. ww. Model Number: DYNJ41190, UPC Number: 088438989908; Model Number: DYNJ43894A, UPC Number: 088994213269; Model Number: DYNJ44087A, UPC Number: 088994256180; Model Number: DYNJ44524F, UPC Number: 019348946748; Model Number: DYNJ52806C, UPC Number: 019348929290. xx. Model Number: DYNJVB1000, UPC Number: 019348980099. yy. Model Number: DYNJ69742, UPC Number: 019348997490; Model Number: DYNJ69742B, UPC Number: 019532713688. zz. Model Number: ECVC2930, UPC Number: 10653160335368; Model Number: ECVC5835, UPC Number: 10653160333364. aaa. Model Number: DYNJ82030, UPC Number: 019532716237. bbb. Model Number: DYNJ82041, UPC Number: 019532716221. ccc. Model Number: DYNJ68729, UPC Number: 019348983654. ddd. Model Number: DYNJ38314G, UPC Number: 019348960334. eee. Model Number: DYNJ0416535AA, UPC Number: 019532735459; Model Number: DYNJ0416535W, UPC Number: 019348956435; Model Number: DYNJ0458661C, UPC Number: 088994255094. fff. Model Number: DYNJ0604508R, UPC Number: 019348982844. ggg. Model Number: DYNJ23288C, UPC Number: 019348995414. hhh. Model Number: DYNJ67136A, UPC Number: 019348993567. iii. Model Number: ECVC7465A, UPC Number: 10653160350088. jjj. Model Number: ECVC8100, UPC Number: 10653160357841. kkk. Model Number: DYNJ27613J, UPC Number: 019348956435; Model Number: DYNJ27613K, UPC Number: 019532713118. lll. Model Number: DYNJ80925, UPC Number: 019532708511. mmm. Model Number: DYNJ52425J, UPC Number: 019348994014. nnn. Model Number: DYNJ83251, UPC Number: 019532724865. ooo. Model Number: ECVC7310, UPC Number: 10653160345060; Model Number: ECVC7310A, UPC Number: 10653160352792. ppp. Model Number: ECVC2965, UPC Number: 10653160338611; Model Number: ECVC3155, UPC Number: 10653160334132; Model Number: ECVC5475, UPC Number: 10653160338116. qqq. Model Number: ECVC5015, UPC Number: 10653160338956. rrr. Model Number: ECVC3395, UPC Number: 10653160338635. sss. Model Number: ECVC5810, UPC Number: 10653160336419. ttt. Model Number: ECVC255, UPC Number: 10653160331735; Model Number: ECVC5200, UPC Number: 10653160336150. uuu. Model Number: ECVC825A, UPC Number: 10653160333548. vvv. Model Number: ECVC7180, UPC Number: 10653160343165. www. Model Number: ECVC7425, UPC Number: 10653160347699; Model Number: STCVC2040, UPC Number: 10653160336785; Model Number: STCVC2040A, UPC Number: 10653160345701. xxx. Model Number: ECVC7290, UPC Number: 10653160344933. yyy. Model Number: ECVC5355B, UPC Number: 10653160357742. zzz. Model Number: ECVC6020A, UPC Number: 10653160338413. aaaa. Model Number: ECVC1910, UPC Number:10653160334453; Model Number: ECVC5870A, UPC Number:10653160338383. bbbb. Model Number: ECVC6055A, UPC Number: 10653160335849. cccc. Model Number: ECVC6540, UPC Number: 10653160339397. dddd. Model Number: ECVC3735A, UPC Number: 10653160334798. eeee. Model Number: ECVC3355, UPC Number: 10653160333982; Model Number: ECVC3400, UPC Number: 10653160340591; Model Number: ECVC3460, UPC Number: 10653160332794; Model Number: ECVC3785, UPC Number: 10653160336006; Model Number: ECVC3810, UPC Number: 10653160336013; Model Number: ECVC4880, UPC Number: 10653160333111; Model Number: ECVC5020, UPC Number: 10653160334903; Model Number: ECVC5020A, UPC Number: 10653160358251; Model Number: ECVC5125, UPC Number: 10653160334934; Model Number: ECVC5270, UPC Number: 10653160336198; Model Number: ECVC6395, UPC Number: 10653160336372. ffff. Model Number: ECVC1490, UPC Number: 10653160332183; Model Number: ECVC1490A, UPC Number: 10653160359036; Model Number: ECVC1495, UPC Number: 10653160334569; Model Number: ECVC1495A, UPC Number: 10653160358794. gggg. Model Number: ECVC1710, UPC Number: 10653160332268. hhhh. Model Number: ECVC5815, UPC Number: 10653160336402. iiii. Model Number: DYNJ67990A, UPC Number: 019532726533. jjjj.Model Number: DYNJ41562F, UPC Number: 019348964108. kkkk. Model Number: DYNJ41562D, UPC Number: 019348958812. llll. Model Number: ECVC1655, UPC Number: 10653160254935. mmmm. Model Number: ECVC7170, UPC Number: 10653160333524. nnnn. Model Number: ECVC6680, UPC Number: 10653160337867; Model Number: ECVC6680A, UPC Number: 10653160337164. oooo. Model Number: ECVC6675, UPC Number: 10653160337850; Model Number: ECVC6675A, UPC Number: 10653160336617. pppp. Model Number: ECVC7970, UPC Number: 10653160353980. qqqq. Model Number: ECVC6815, UPC Number: 10653160335115. rrrr. Model Number: ECVC6840, UPC Number: 10653160336761. ssss. Model Number: ECVC6835, UPC Number: 10653160336778. tttt. Model Number: ECVC7485, UPC Number: 10653160354802. uuuu. Model Number: ECVC7615, UPC Number: 10653160348009; Model Number: ECVC7690, UPC Number: 10653160348153. vvvv. Model Number: ECVC6630, UPC Number: 10653160337492. wwww. Model Number: ECVC6690, UPC Number: 10653160336600. xxxx. Model Number: ECVC8135, UPC Number: 10653160358558; Model Number: ECVC8160, UPC Number: 10653160358404. yyyy. Model Number: ECVC7915, UPC Number: 10653160353355. zzzz. Model Number: ECVC6550, UPC Number: 10653160335276; Model Number: ECVC6595, UPC Number: 10653160337485; Model Number: ECVC7115B, UPC Number: 10653160350279; Model Number: ECVC7275, UPC Number: 10653160342700; Model Number: ECVC7275A, UPC Number: 10653160344292; Model Number: ECVC8015, UPC Number: 10653160355366. aaaaa. Model Number: ECVC7400, UPC Number: 10193489199956; Model Number: ECVC7960, UPC Number: 10653160353881; Model Number: ECVC8050, UPC Number: 10653160355601. bbbbb. Model Number: ECVC7945, UPC Number: 10653160353966. ccccc. Model Number: ECVC7625, UPC Number: 10653160356295. ddddd. Model Number: ECVC7895, UPC Number: 10653160355328. eeeee. Model Number: STCVC02US, UPC Number: 10653160336815; Model Number: STCVC02UST, UPC Number: 10653160358589. fffff. Model Number: ECVC7405, UPC Number: 10653160347132. ggggg. Model Number: ECVC7295, UPC Number: 10653160344650. hhhhh. Model Number: ECVC6765, UPC Number: 10653160336839. iiiii. Model Number: ECVC7495B, UPC Number: 10653160355748. jjjjj. Model Number: ECVC6505, UPC Number: 10653160336327; Model Number: ECVC7300, UPC Number: 10653160344698. kkkkk. Model Number: ECVC7560, UPC Number: 10653160347705; Model Number: ECVC7955, UPC Number: 10653160353867; Model Number: ECVC8020, UPC Number: 10653160355458; Model Number: ECVC8045, UPC Number: 10653160355595; Model Number: ECVC8085, UPC Number: 10653160356905. lllll. Model Number: ECVC8025, UPC Number: 10653160355434. mmmmm. Model Number: ECVC8040, UPC Number: 10653160355700. nnnnn. Model Number: ECVC7565, UPC Number: 10653160347682. ooooo. Model Number: ECVC7830A, UPC Number: 10653160355342. ppppp. Model Number: STCVC01US, UPC Number: 10653160336846; Model Number: STCVC01UST, UPC Number: 10653160358565. qqqqq. Model Number: ECVC7630, UPC Number: 10653160347750. rrrrr. Model Number: ECVC6050A, UPC Number: 10653160335894; Model Number: ECVC6670, UPC Number: 10653160336624; Model Number: ECVC7660, UPC Number: 10653160347804. sssss. Model Number: ECVC7385, UPC Number: 10653160346210; Model Number: ECVC7385A, UPC Number: 10653160347392; Model Number: ECVC7700, UPC Number: 10653160348375. ttttt. Model Number: ECVC5595, UPC Number: 10653160336495. uuuuu. Model Number: ECVC6800, UPC Number: 10653160335092. vvvvv. Model Number: ECVC7785, UPC Number: 10653160349365. wwwww. Model Number: ECVC6825A, UPC Number: 10653160336631. xxxxx. Model Number: ECVC7505A, UPC Number: 10653160352853. yyyyy. Model Number: ECVC7835A, UPC Number: 10653160355359. zzzzz. Model Number: ECVC8080, UPC Number: 10653160356899. aaaaaa. Model Number: STCVC06US, UPC Number: 10653160338314. bbbbbb. Model Number: ECVC1320, UPC Number: 10653160335795. cccccc. Model Number: ECVC6255, UPC Number: 10653160336525. dddddd. Model Number: ECVC6260, UPC Number: 10653160336488. eeeeee. Model Number: ECVC5080, UPC Number: 10653160337690. ffffff. Model Number: ECVC6920, UPC Number: 10653160336716; Model Number: ECVC7000, UPC Number: 10193489196399. gggggg. Model Number: ECVC6915, UPC Number: 10653160336723; Model Number: ECVC6975, UPC Number: 10653160336679. hhhhhh. Model Number: ECVC4105, UPC Number: 10653160334835. iiiiii. Model Number: ECVC6340A, UPC Number: 10653160355038. jjjjjj. Model Number: DYNJ0429121K, UPC Number: 019532706950. kkkkkk. Model Number: ECVC7330, UPC Number: 10653160345565.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, 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
49 other products · FDA event 92399This product is part of a recall event; the main page for the event is Custom Sterile and Non-Sterile Procedural Kits recalled.
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