| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | October 09, 2024 |
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| Date Posted | December 05, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0640-2025 |
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| Recall Event ID |
95621 |
| Product Classification |
Neurological tray - Product Code OJG
|
| 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) 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 |
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| Code Information |
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 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | 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.
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| Quantity in Commerce | 12847 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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