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MEDLINE convenience kits labeled as recallZ-0640-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Oct 9, 2024

Class II Open, Classified All recalls posted in December 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.

Recall details

Recall number
Z-0640-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Oct 9, 2024
Posted by the FDA
Dec 5, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
12847 units
Product code
OJG
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (6k characters)

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

Devices named in this recall

46 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95621).

Sources and updates

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