Z-1049-2025 Class II Ongoing
FDA device recall Z-1049-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on December 23, 2024 and is designated Class II. Reason for recall: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed. The recall status is ongoing. Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- December 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Reason for Recall
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Distribution Pattern
US: FL, KS, ND, PA, WA, WV, IL, WA
Code Information
UDI/DI 10195327561543 (ea) 40195327561544 (cs), Lot Numbers: 24IMA276, 24JMI065, 24FMF777, 24GMG420