FDA Device recall Z-1276-2024
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile by Convatec, citing the kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1276-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-17 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Convatec |
| Distribution | AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, TX |
Product
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Reason
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Identifiers
| code_info | Lot #2C02496, UDI-DI #00768455116096. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1276-2024%22
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