| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | February 11, 2025 |
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| Date Posted | March 25, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1436-2025 |
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| Recall Event ID |
96374 |
| Product Classification |
Angiography/angioplasty kit - Product Code OEQ
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| Product | Medline procedure kits labeled as:
1) ANGIO PACK, Pack Number DYNJ50624A;
2) ANGIO PACK, Pack Number DYNJ30501F;
3) ANGIO PACK-LF, Pack Number DYNJ0954970G;
4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J;
5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B;
6) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ42873;
7) ANGIOGRAPHY PACK, Pack Number DYNJ57498;
8) ANGIOGRAPHY PACK, Pack Number DYNJ52167A;
9) ANGIOGRAPHY PACK, Pack Number DYNJV0173I;
10) ANGIOGRAPHY TRAY-LF, Pack Number DYNJ58722A;
11) CATH LAB PACK, Pack Number DYNJ42912F;
12) CATH LAB PK, Pack Number DYNJ35643B;
13) CATH PACK-LF, Pack Number DYNJ0367643Q;
14) CRMS ANGIO PACK-LF, Pack Number PHS616026002A;
15) DEPAUL ANGIO CATH PACK, Pack Number DYNJ24542L |
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| Code Information |
1) Pack Number DYNJ50624A: UDI/DI 10889942474639 (each) 40889942474630 (case), Lot Number 20BDB393A;
2) Pack Number DYNJ30501F: UDI/DI 10889942806683 (each) 40889942806684 (case), Lot Number 21HBP134A;
3) Pack Number DYNJ0954970G: UDI/DI 10193489505634 (each) 40193489505635 (case), Lot Number 21GMA850A;
4) Pack Number DYNJ33597J: UDI/DI 10889942802012 (each) 40889942802013 (case), Lot Number 21IMD296A;
5) Pack Number DYNJ38120B: UDI/DI 10884389722145 (each) 40884389722146 (case), Lot Number 21BBI114A;
6) Pack Number DYNJ42873: UDI/DI 10888277011298 (each) 40888277011299 (case), Lot Number 23EBE560A;
7) Pack Number DYNJ57498: UDI/DI 10889942745746 (each) 40889942745747 (case), Lot Number 21AMA569A;
8) Pack Number DYNJ52167A: UDI/DI 10193489541106 (each) 40193489541107 (case), Lot Number 21GMB606A;
9) Pack Number DYNJV0173I: UDI/DI 10889942965021 (each) 40889942965022 (case), Lot Number 23CLA070A;
10) Pack Number DYNJ58722A: UDI/DI 10193489329698 (each) 40193489329699 (case), Lot Number 21IME955A;
11) Pack Number DYNJ42912F: UDI/DI 10193489785753 (each) 40193489785754 (case), Lot Number 23LBU921Z;
12) Pack Number DYNJ35643B: UDI/DI 10193489223712 (each) 40193489223713 (case), Lot Number 21BBG490A;
13) Pack Number DYNJ0367643Q: UDI/DI 10193489648614 (each) 40193489648615 (case), Lot Number 23EBE428A;
14) Pack Number PHS616026002A: UDI/DI 10889942429370 (each) 40889942429371 (case), Lot Number 23BBS889A;
15) Pack Number DYNJ24542L: UDI/DI 10193489651119 (each) 40193489651110 (case), Lot Number 20FBN798A
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| FEI Number |
1417592
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers.
This is an expansion of RES 94583 |
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| Quantity in Commerce | 1939 units |
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| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
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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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