Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-1436-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) ANGIO PACK

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Apr 2, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

Lot #
20BDB393A; 2) Pack Number DYNJ30501F: UDI/DI 10889942806683 (each) 40889942806684 (case)
Lot #
21HBP134A; 3) Pack Number DYNJ0954970G: UDI/DI 10193489505634 (each) 40193489505635 (case)
Lot #
21GMA850A; 4) Pack Number DYNJ33597J: UDI/DI 10889942802012 (each) 40889942802013 (case)
Lot #
21IMD296A; 5) Pack Number DYNJ38120B: UDI/DI 10884389722145 (each) 40884389722146 (case)
Lot #
21BBI114A; 6) Pack Number DYNJ42873: UDI/DI 10888277011298 (each) 40888277011299 (case)
Lot #
23EBE560A; 7) Pack Number DYNJ57498: UDI/DI 10889942745746 (each) 40889942745747 (case)
Lot #
21AMA569A; 8) Pack Number DYNJ52167A: UDI/DI 10193489541106 (each) 40193489541107 (case)
Lot #
21GMB606A; 9) Pack Number DYNJV0173I: UDI/DI 10889942965021 (each) 40889942965022 (case)
Lot #
23CLA070A; 10) Pack Number DYNJ58722A: UDI/DI 10193489329698 (each) 40193489329699 (case)
Lot #
21IME955A; 11) Pack Number DYNJ42912F: UDI/DI 10193489785753 (each) 40193489785754 (case)
Show 5 more code fields
Lot #
23LBU921Z; 12) Pack Number DYNJ35643B: UDI/DI 10193489223712 (each) 40193489223713 (case)
Lot #
21BBG490A; 13) Pack Number DYNJ0367643Q: UDI/DI 10193489648614 (each) 40193489648615 (case)
Lot #
23EBE428A; 14) Pack Number PHS616026002A: UDI/DI 10889942429370 (each) 40889942429371 (case)
Lot #
23BBS889A; 15) Pack Number DYNJ24542L: UDI/DI 10193489651119 (each) 40193489651110 (case)
Lot #
20FBN798A

What the firm is doing

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

DistributionShow details

Worldwide distribution - US Nationwide and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls