Z-1368-2025 Class II Ongoing
FDA device recall Z-1368-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on February 13, 2025 and is designated Class II. Reason for recall: Potential breach in pouch packaging which could lead to loss of sterility. The recall status is ongoing. Affected quantity: 2,422 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,422 units
Product Description
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
Reason for Recall
Potential breach in pouch packaging which could lead to loss of sterility.
Distribution Pattern
US Nationwide distribution.
Code Information
Item No. DYNJ35520B, DYNJ38529F, DYNJ43406F, DYNJ43421D, DYNJ69185A, DYNJ69340B, DYNJ88923; UDI (case): 40198459106904, 40195327693870, 40198459074005, 40198459074784, 40195327582839, 40198459026127, 40198459216856; UDI (each): 10198459106903, 10195327693879, 10198459074004, 10198459074783, 10195327582838, 10198459026126, 10198459216855; Lot No. (Shelf Life) 24KMB843(05/31/2027), 24IMD400(01/31/2027), 24IMB784(01/31/2027), 24LBK460(02/28/2027), 24JBY288(12/31/2026), 24LBJ155(01/31/2027), 24JBU154(12/31/2026), 24HBP361(11/30/2026), 24HBA919(10/31/2026), 24JBX700(06/30/2026), 24JBC370(04/30/2026), 24IBI711(04/30/2026), 24HBO453(04/30/2026), 24HBA954(01/31/2026), 24JBK365(04/30/2026), 24HBR810(04/30/2026), 24GBX503(03/31/2026), 24LBO297(06/30/2026), 24JBV432(06/30/2026), 24IBU974(05/31/2026), 24HBR072(04/30/2026), 25ABB569(02/10/2026).