FDA Device recall Z-0128-2023
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975
- FDA Device
- Class II
- ongoing
- Published 2022-11-02
On 2022-11-02 the FDA classified a Class II recall of ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975 by Convatec, citing impaired functionality of the release liner.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0128-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-16 |
| Published | 2022-11-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Convatec |
| Distribution | US |
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.
Reason
impaired functionality of the release liner
Identifiers
| code_info | UDI/DI: 768455115334, Batch Number: 2A02671 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0128-2023%22
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