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Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2...

FDA Device Recall #Z-1437-2025 — Class II — February 11, 2025

Recall Summary

Recall Number Z-1437-2025
Classification Class II — Moderate risk
Date Initiated February 11, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 9246 units

Product Description

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

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.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Lot / Code Information

1) Pack Number DYNJ47718D: UDI/DI 10195327528331 (each) 40195327528332 (case), Lot Number 23LME887A; 2) Pack Number DYNJ69678: UDI/DI 10193489968156 (each) 40193489968157 (case), Lot Number 23EMD520A; 3) Pack Number DYNJ64936A: UDI/DI 10193489978759 (each) 40193489978750 (case), Lot Number 21LBW389A; 4) Pack Number DYNJ49621C: UDI/DI 10195327008581 (each) 40195327008582 (case), Lot Number 23LMG954A; 5) Pack Number DYNJ61266A: UDI/DI 10195327057763 (each) 40195327057764 (case), Lot Number 23GBF536A; 6) Pack Number DYNJ35916N: UDI/DI 10195327223977 (each) 40195327223978 (case), Lot Number 23EBE626A; 7) Pack Number DYNJ34442F: UDI/DI 10193489881424 (each) 40193489881425 (case), Lot Number 23LMG342A; 8) Pack Number DYNJ53588I: UDI/DI 10195327014001 (each) 40195327014002 (case), Lot Number 23EME005A; 9) Pack Number DYNJ31733C: UDI/DI 10889942875290 (each) 40889942875291 (case), Lot Number 21BBG459B; 10) Pack Number DYNJ41315A: UDI/DI 10888277907089 (each) 40888277907080 (case), Lot Number 22LBA182A; 11) Pack Number DYNJ0380198L: UDI/DI 10193489916478 (each) 40193489916479 (case), Lot Number 22GBH915A; 12) Pack Number 0M-CP31796Q: UDI/DI 10889942756483 (each) 40889942756484 (case), Lot Number 21HBP168A; 13) Pack Number DYNJ0194968AG: UDI/DI 10195327179557 (each) 40195327179558 (case), Lot Number 24AME980A; 14) Pack Number 00-401610J: UDI/DI 10889942731640 (each) 40889942731641 (case), Lot Number 23LBL085Z; 15) Pack Number DYNJ60931C: UDI/DI 10193489952940 (each) 40193489952941 (case), Lot Number 21JMI207A; 16) Pack Number DYNJ61088F: UDI/DI 10195327451585 (each) 40195327451586 (case), Lot Number 23LMG703A; 17) Pack Number DYNJ61101D: UDI/DI 10195327451813 (each) 40195327451814 (case), Lot Number 23HME348A; 18) Pack Number DYNJ69301: UDI/DI 10193489926101 (each) 40193489926102 (case), Lot Number 23CBL353A; 19) Pack Number DYNJ68812C: UDI/DI 10195327449452 (each) 40195327449453 (case), Lot Number 23KMC169A; 20) Pack Number DYNJ24615D: UDI/DI 10889942436057 (each) 40889942436058 (case), Lot Number 21JMF491A; 21) Pack Number DYNJ54253: UDI/DI 10889942474509 (each) 40889942474500 (case), Lot Number 20KBM762A; 22) Pack Number PHS605358025B: UDI/DI 10193489498998 (each) 40193489498999 (case), Lot Number 23FMD837A; 23) Pack Number DYNJ58339A: UDI/DI 10193489483147 (each) 40193489483148 (case), Lot Number 21EBP494A; 24) Pack Number DYNJ46934A: UDI/DI 10888277856998 (each) 40888277856999 (case), Lot Number 23BBR783A; 25) Pack Number DYNJ65481: UDI/DI 10193489280463 (each) 40193489280464 (case), Lot Number 23IMG363A; 26) Pack Number DYNJ59628C: UDI/DI 10193489813128 (each) 40193489813129 (case), Lot Number 23LBK499A; 27) Pack Number DYNJ07252V: UDI/DI 10193489744644 (each) 40193489744645 (case), Lot Number 22HBO256A; 28) Pack Number DYNJ45393A: UDI/DI 10889942188765 (each) 40889942188766 (case), Lot Number 20FMA718A; 29) Pack Number DYNJ0608549M: UDI/DI 10195327477387 (each) 40195327477388 (case), Lot Number 23LMD710A; 30) Pack Number DYNJ47586F: UDI/DI 10195327400156 (each) 40195327400157 (case), Lot Number 23LME689A; 31) Pack Number DYNJ69504: UDI/DI 10193489950243 (each) 40193489950244 (case), Lot Number 24ABA461Z; 32) Pack Number DYNJ41564P: UDI/DI 10195327177423 (each) 40195327177424 (case), Lot Number 23HMB245A; 33) Pack Number DYNJ41564P: UDI/DI 10195327177423 (each) 40195327177424 (case), Lot Number 23HMC543A; 34) Pack Number DYNJ68672C: UDI/DI 10195327191566 (each) 40195327191567 (case), Lot Number 23BBR790A

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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