Device product
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Z-1049-2025
Product summary
- Event
- Event 96066
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-1049-2025
Official wording
Reason: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Code information: UDI/DI 10195327561543 (ea) 40195327561544 (cs), Lot Numbers: 24IMA276, 24JMI065, 24FMF777, 24GMG420
Distribution pattern: US: FL, KS, ND, PA, WA, WV, IL, WA
Derived failure modes
-
Labeling or packaging
mislabeled