Z-1495-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2024
- Initiation Date
- February 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 market units
Product Description
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
Reason for Recall
The product does not meet sterility assurance level.
Distribution Pattern
US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
Code Information
Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.