FDAClass IIDecember 11, 2024

MEDLINE convenience kits labeled as: 1) BASIC NEURO recall

MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4)…

Why was MEDLINE convenience kits labeled as: 1) BASIC NEURO recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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

Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4)…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
12847 units
Distribution
US Nationwide distribution.
Recall date
December 11, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls