Device product
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.
Z-0128-2023
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 90856
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 182 units
- Official record key
device-enforcement:Z-0128-2023
Official wording
Reason: impaired functionality of the release liner
Code information: UDI/DI: 768455115334, Batch Number: 2A02671
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
impaired functionality of the release liner