Recall archive / FDA device enforcement
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number... — FDA record Z-1437-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 9246 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1437-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 2, 2025
- Recall initiation date
- Feb 11, 2025
- Center classification date
- Mar 25, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.