Z-1276-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2024
- Initiation Date
- January 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,715 units
Product Description
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Reason for Recall
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Distribution Pattern
Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Canada.
Code Information
Lot #2C02496, UDI-DI #00768455116096.