Z-1365-2025 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
- 114 units
Product Description
Proxima Drape labeled as ENT-PLASTICS 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. DYNJ84258A & DYNJ84258B; UDI (case): 40195327650743 & 40198459117986; UDI (each): 10195327650742 & 10198459117985; Lot No. (Shelf Life) 24HBK264 (12/31/26) & 24IBD271 (7/31/26). .