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RecallWatchMedical Device Safety
Class IIOngoingZ-1437-2025

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

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 DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ61266A; 6) ANGIOGRAPHY PACK-LF, Pack Number DYNJ35916N; 7) ARTERIOGRAM PACK, Pack Number DYNJ34442F; 8) CARDIAC CATH FEMORAL PACK, Pack Number DYNJ53588I; 9) CARDIAC CATH PACK, Pack Number DYNJ31733C; 10) CARDIAC CATH PACK, Pack Number DYNJ41315A; 11) CARDIAC CATH PACK-LF, Pack Number DYNJ0380198L; 12) CATH LAB PACK, Pack Number 0M-CP31796Q; 13) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 14) CATH LAB TRAY, Pack Number 00-401610J; 15) CHRISTUS SR CATH LAB PACK, Pack Number DYNJ60931C; 16) CRMC CATH LAB TRAY JUDKINS-LF, Pack Number DYNJ61088F; 17) CRMC NEURO ENDO HYBRID-LF, Pack Number DYNJ61101D; 18) EP PACK MORNINGSIDE, Pack Number DYNJ69301; 19) FEMORAL TRAY 2, Pack Number DYNJ68812C; 20) INTERVENTIONAL MINOR PACK, Pack Number DYNJ24615D; 21) INTERVENTIONAL PACK, Pack Number DYNJ54253; 22) INTERVENTIONAL RADIOLOGY PK-LF, Pack Number PHS605358025B; 23) MORNINGSIDE CARDIAC CATH, Pack Number DYNJ58339A; 24) OR INTERVENTIONAL PACK, Pack Number DYNJ46934A; 25) PACK,CARDIAC CATH, Pack Number DYNJ65481; 26) PK, RADIOLOGY-SPECIALS, Pack Number DYNJ59628C; 27) PTCA TRAY-LF, Pack Number DYNJ07252V; 28) RADIOLOGY PACK, Pack Number DYNJ45393A; 29) RR-ANGIOGRAPHY DRAPE PACK-LF, Pack Number DYNJ0608549M; 30) SPEC ANGIO PACK (SASJK)642-LF, Pack Number DYNJ47586F; 31) SPECIALS LINE PACK, Pack Number DYNJ69504; 32) TV-CARDIAC CATH PACK-LF, Pack Number DYNJ41564P; 33) TV-CARDIAC CATH PACK-LF, Pack Number DYNJ41564P; 34) UTHET TYLER ELECTROPHYSIOLOGY, Pack Number DYNJ68672C

Lot / code information

Lot #
23LME887A; 2) Pack Number DYNJ69678: UDI/DI 10193489968156 (each) 40193489968157 (case)
Lot #
23EMD520A; 3) Pack Number DYNJ64936A: UDI/DI 10193489978759 (each) 40193489978750 (case)
Lot #
21LBW389A; 4) Pack Number DYNJ49621C: UDI/DI 10195327008581 (each) 40195327008582 (case)
Lot #
23LMG954A; 5) Pack Number DYNJ61266A: UDI/DI 10195327057763 (each) 40195327057764 (case)
Lot #
23GBF536A; 6) Pack Number DYNJ35916N: UDI/DI 10195327223977 (each) 40195327223978 (case)
Lot #
23EBE626A; 7) Pack Number DYNJ34442F: UDI/DI 10193489881424 (each) 40193489881425 (case)
Lot #
23LMG342A; 8) Pack Number DYNJ53588I: UDI/DI 10195327014001 (each) 40195327014002 (case)
Lot #
23EME005A; 9) Pack Number DYNJ31733C: UDI/DI 10889942875290 (each) 40889942875291 (case)
Lot #
21BBG459B; 10) Pack Number DYNJ41315A: UDI/DI 10888277907089 (each) 40888277907080 (case)
Lot #
22LBA182A; 11) Pack Number DYNJ0380198L: UDI/DI 10193489916478 (each) 40193489916479 (case)
Show 24 more code fields
Lot #
22GBH915A; 12) Pack Number 0M-CP31796Q: UDI/DI 10889942756483 (each) 40889942756484 (case)
Lot #
21HBP168A; 13) Pack Number DYNJ0194968AG: UDI/DI 10195327179557 (each) 40195327179558 (case)
Lot #
24AME980A; 14) Pack Number 00-401610J: UDI/DI 10889942731640 (each) 40889942731641 (case)
Lot #
23LBL085Z; 15) Pack Number DYNJ60931C: UDI/DI 10193489952940 (each) 40193489952941 (case)
Lot #
21JMI207A; 16) Pack Number DYNJ61088F: UDI/DI 10195327451585 (each) 40195327451586 (case)
Lot #
23LMG703A; 17) Pack Number DYNJ61101D: UDI/DI 10195327451813 (each) 40195327451814 (case)
Lot #
23HME348A; 18) Pack Number DYNJ69301: UDI/DI 10193489926101 (each) 40193489926102 (case)
Lot #
23CBL353A; 19) Pack Number DYNJ68812C: UDI/DI 10195327449452 (each) 40195327449453 (case)
Lot #
23KMC169A; 20) Pack Number DYNJ24615D: UDI/DI 10889942436057 (each) 40889942436058 (case)
Lot #
21JMF491A; 21) Pack Number DYNJ54253: UDI/DI 10889942474509 (each) 40889942474500 (case)
Lot #
20KBM762A; 22) Pack Number PHS605358025B: UDI/DI 10193489498998 (each) 40193489498999 (case)
Lot #
23FMD837A; 23) Pack Number DYNJ58339A: UDI/DI 10193489483147 (each) 40193489483148 (case)
Lot #
21EBP494A; 24) Pack Number DYNJ46934A: UDI/DI 10888277856998 (each) 40888277856999 (case)
Lot #
23BBR783A; 25) Pack Number DYNJ65481: UDI/DI 10193489280463 (each) 40193489280464 (case)
Lot #
23IMG363A; 26) Pack Number DYNJ59628C: UDI/DI 10193489813128 (each) 40193489813129 (case)
Lot #
23LBK499A; 27) Pack Number DYNJ07252V: UDI/DI 10193489744644 (each) 40193489744645 (case)
Lot #
22HBO256A; 28) Pack Number DYNJ45393A: UDI/DI 10889942188765 (each) 40889942188766 (case)
Lot #
20FMA718A; 29) Pack Number DYNJ0608549M: UDI/DI 10195327477387 (each) 40195327477388 (case)
Lot #
23LMD710A; 30) Pack Number DYNJ47586F: UDI/DI 10195327400156 (each) 40195327400157 (case)
Lot #
23LME689A; 31) Pack Number DYNJ69504: UDI/DI 10193489950243 (each) 40193489950244 (case)
Lot #
24ABA461Z; 32) Pack Number DYNJ41564P: UDI/DI 10195327177423 (each) 40195327177424 (case)
Lot #
23HMB245A; 33) Pack Number DYNJ41564P: UDI/DI 10195327177423 (each) 40195327177424 (case)
Lot #
23HMC543A; 34) Pack Number DYNJ68672C: UDI/DI 10195327191566 (each) 40195327191567 (case)
Lot #
23BBR790A

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.

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