CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report
Medline convenience kits labeled as: Basic Neuro Pack recalled
Medline Industries LP - Northfield is recalling Medline convenience kits labeled as: Basic Neuro Pack, distributed nationwide in the US. The recall was initiated on 9 Oct 2024 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-0640-2025
- FDA event ID
- 95621
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2024
- FDA classified
- 5 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 9 Oct 2024 | Recall initiated by company | |
| 5 Dec 2024 | Classified by FDA | +57 days |
| 11 Dec 2024 | 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
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Product as listed by the FDA
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, REF DYNJ0038440C; 8) NEURO PACK-LF, REF DYNJ0406347M; 9) NEURO-LF, REF DYNJ0484186M; 10) NEURO-LF, REF DYNJ0484186N; 11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K; 12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 13) NEURO-ORTHO EXTRAS, REF DYNJ44882L; 14) NEURO PACK, REF DYNJ57785B; 15) NEURO PACK, REF DYNJ60825B; 16) CHRISTUS MC NEURO PACK, REF DYNJ61157C; 17) CHRISTUS CHILDRENS NEURO PK, REF DYNJ61168C; 18) CHRISTUS CHILDRENS VP SHUNT PK, REF DYNJ61174C; 19) AFCH SHUNT, REF DYNJ63317C; 20) NEURO SPINE PK, REF DYNJ63319D; 21) NEURO CAROTID ENDARTERECTO, REF DYNJ63321D; 22) DBS PACK, REF DYNJ63322A; 23) NEURO LAM, REF DYNJ64188B; 24) PACK,V-P SHUNT, REF DYNJ65472B; 25) NEURO PK, REF DYNJ66735A; 26) DR. FONTES ADD-ON PK-LF, REF DYNJ66766B; 27) NEURO PACK, REF DYNJ68558A; 28) NEURO PACK, REF DYNJ69019C; 29) VP SHUNT, REF DYNJ81866A; 30) VP SHUNT, REF DYNJ81866B; 31) VP SHUNT, REF DYNJ81866C; 32) NEURO PACK, REF DYNJ84058A; 33) NEURO, REF DYNJ900420O; 34) CRANIO / NEURO / SPINE, REF DYNJ901072G; 35) CRANIO / NEURO / SPINE, REF DYNJ901072I; 36) LAMINECTOMY, REF DYNJ903870F; 37) MINOR NEURO, REF DYNJ904859C; 38) MINOR NEURO, REF DYNJ904859D; 39) MINOR NEURO, REF DYNJ904859F; 40) NEURO, REF DYNJ904861B; 41) NEURO, REF DYNJ904861D; 42) NEURO, REF DYNJ904861F; 43) NEURO, REF DYNJ904861G; 44) KIT V P SHUNT, REF DYNJ908835A; 45) GENERAL NEURO, REF DYNJ909744
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Which lots are affected?
84OJG 1) REF CDS780202P, UDI/DI 10195327096458 (each) 40195327096459 (case), Lot Numbers: 22IMA512, 22IMA513, 22FMD852, 22GME200, 22FMH471, 22LMA065; 2) REF CDS780202Q, UDI/DI 10195327265304 (each) 40195327265305 (case), Lot Numbers: 22LMA225, 23EME852, 23DME052; 3) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers: 23FMI343, 4) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers: 22EBB662, 22JBR840, 23ABG194, 23DBM361, 23BBR105; 5) REF CDS981327Q, UDI/DI 10195327080365 (each) 40195327080366 (case), Lot Numbers: 22GMH480, 22FMF883, 22FMH830, 23JMG480, 23CMF104, 23BMH848, 23BMG193, 23BMG197, 23KMF371, 23IMG472; 6) REF CDS983186J, UDI/DI 10195327105624 (each) 40195327105625 (case), Lot Numbers: 23CBO871, 22EBV250, 22EBU143, 23DBA498, 23DBO557; 7) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers: 23GMC512, 23GMC697; 8) REF DYNJ0406347M, UDI/DI 10195327510701 (each) 40195327510702 (case), Lot Numbers: 23JMH534; 9) REF DYNJ0484186M, UDI/DI 10195327046057 (each) 40195327046058 (case), Lot Numbers: 22EBF993, 22GBB271, 22FBF013; 10) REF DYNJ0484186N, UDI/DI 10195327204150 (each) 40195327204151 (case), Lot Numbers: 22JBX539, 22IBD332, 23FBB054, 23DBI625, 23GBL780; 11) REF DYNJ0843121K, UDI/DI 10195327286491 (each) 40195327286492 (case), Lot Numbers: 23IDC125, 23EDB879, 23DDB255, 23GDA826; 12) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers: 22EBN168, 22EBB079, 22HBY426, 22EBB077, 22IBS173, 22JBV775, 22JBW872, 23ABK720, 23ABB556; 13) REF DYNJ44882L, UDI/DI 10195327127725 (each) 40195327127726 (case), Lot Numbers: 22FDA475, 22LDA151, 22KDA751, 22HDA703, 23BDC150, 23ADB774, 22IDB866; 14) REF DYNJ57785B, UDI/DI 10195327072643 (each) 40195327072644 (case), Lot Numbers: 22GMF726, 22FMD430, 23AMF372, 23HMD358, 23JME934; 15) REF DYNJ60825B, UDI/DI 10195327521301 (each) 40195327521302 (case), Lot Numbers: 23KBE951, 23JBH391; 16) REF DYNJ61157C, UDI/DI 10195327470234 (each) 40195327470235 (case), Lot Numbers: 23IBP298; 17) REF DYNJ61168C, UDI/DI 10195327470197 (each) 40195327470198 (case), Lot Numbers: 23IBQ047; 18) REF DYNJ61174C, UDI/DI 10195327470203 (each) 40195327470204 (case), Lot Numbers: 23ILA859, 23HLB095; 19) REF DYNJ63317C, UDI/DI 10195327273446 (each) 40195327273447 (case), Lot Numbers: 23AMG481, 23BMC514, 23JMG245; 20) REF DYNJ63319D, UDI/DI 10195327402167 (each) 40195327402168 (case), Lot Numbers: 23FMG396, 23KMI427; 21) REF DYNJ63321D, UDI/DI 10195327404154 (each) 40195327404155 (case), Lot Numbers: 23GMH332; 22) REF DYNJ63322A, UDI/DI 10193489958058 (each) 40193489958059 (case), Lot Numbers: 22FBX778; 23) REF DYNJ64188B, UDI/DI 10195327279721 (each) 40195327279722 (case), Lot Numbers: 22LBE618, 23BBD435, 23ABJ723, 22LBP476, 23FBR198, 23JBE272; 24) REF DYNJ65472B, UDI/DI 10195327303396 (each) 40195327303397 (case), Lot Numbers: 23AMI025, 22LMJ219, 23DMB323, 23JMJ552; 25) REF DYNJ66735A, UDI/DI 10195327504755 (each) 40195327504756 (case), Lot Numbers: 23KBC296, 23JBT150, 23KBL436, 24DBV652; 26) REF DYNJ66766B, UDI/DI 10195327286286 (each) 40195327286287 (case), Lot Numbers: 23HMH943; 27) REF DYNJ68558A, UDI/DI 10193489994926 (each) 40193489994927 (case), Lot Numbers: 22GBT930, 22JBN310, 22LBN425, 22LBE068, 23ABD982, 23FBG228, 23IBG968, 23GBE570; 28) REF DYNJ69019C, UDI/DI 10195327436674 (each) 40195327436675 (case), Lot Numbers: 23GBE293, 23JBL407, 23LBQ035; 29) REF DYNJ81866A, UDI/DI 10195327216467 (each) 40195327216468 (case), Lot Numbers: 22IMF886, 22LMF365; 30) REF DYNJ81866B, UDI/DI 10195327302252 (each) 40195327302253 (case), Lot Numbers: 23BMI434, 23BMC486; 31) REF DYNJ81866C, UDI/DI 10195327417109 (each) 40195327417100 (case), Lot Numbers: 23GMA996, 23HMF910, 23JMC277, 24BMA973, 24AMH042, 23KMF115, 23LMA617, 24EMC255, 24CMH446; 32) REF DYNJ84058A, UDI/DI 10195327358013 (each) 40195327358014 (case), Lot Numbers: 23DBB749; 33) REF DYNJ900420O, UDI/DI 10195327031688 (each) 40195327031689 (case), Lot Numbers: 22LBJ603, 23EBT299, 23EBN052, 23DBA431, 23DBD628, 23GBA726, 24BBK023, 23IBQ476, 23HBO727, 23JBW347, 23JBV912, 23LBI436, 24ABI190, 24DBD086; 34) REF DYNJ901072G, UDI/DI 10195327137540 (each) 40195327137541 (case), Lot Numbers: 22FMG228, 22FMG229, 22HME733; 35) REF DYNJ901072I, UDI/DI 10195327232580 (each) 40195327232581 (case), Lot Numbers: 23AMC161, 22LMB464, 22LMB450, 23CMC880, 23GMC001; 36) REF DYNJ903870F, UDI/DI 10195327239268 (each) 40195327239269 (case), Lot Numbers: 22KBF911; 37) REF DYNJ904859C, UDI/DI 10195327216603 (each) 40195327216604 (case), Lot Numbers: 22IMC571; 38) REF DYNJ904859D, UDI/DI 10195327247959 (each) 40195327247950 (case), Lot Numbers: 23BMI235, 23BMG396, 23BMD402, 23AMC121, 22JME888, 23CMF042; 39) REF DYNJ904859F, UDI/DI 10195327417116 (each) 40195327417117 (case), Lot Numbers: 23GMD960, 23HMI173, 23HMA500, 23FME591, 23IMG713, 23KMC264, 24EMC263, 24BMF111, 24AMD480, 23LMD169, 24CMH460; 40) REF DYNJ904861B, UDI/DI 10195327124786 (each) 40195327124787 (case), Lot Numbers: 22HMA130; 41) REF DYNJ904861D, UDI/DI 10195327247713 (each) 40195327247714 (case), Lot Numbers: 22LMD320, 22JMF457, 23CMB553, 23BMF721; 42) REF DYNJ904861F, UDI/DI 10195327416041 (each) 40195327416042 (case), Lot Numbers: 23JMI908, 23GMH228, 23FME592, 24CME226; 43) REF DYNJ904861G, UDI/DI 10198459004063 (each) 40198459004064 (case), Lot Numbers: 24FME276; 44) REF DYNJ908835A, UDI/DI 10195327546465 (each) 40195327546466 (case), Lot Numbers: 24AMA052, 24HMA162, 24GME380; 45) REF DYNJ909744, UDI/DI 10195327465636 (each) 40195327465637 (case), Lot Numbers: 23JLA320, 24ALA727
Where was it sold?
US Nationwide distribution.
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
26 other products · FDA event 95621This product is part of a recall event; the main page for the event is Medline convenience kits labeled as: Port Insertion Pack recalled.
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