Z-1368-2025 Class II Ongoing
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).