ConvaTec, Inc Recall 93896
Description: ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
ConvaTec, Inc Recall 93896 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1276-2024 |
| Event ID | 93896 |
| Event Description | ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 1,715 units |
| Recall Reason | The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring. |
| Device Classification | 20240313 |
| Device Code Info | Lot #2C02496, UDI-DI #00768455116096. |
| Center Classification Date | 20240307 |
| Recall Initiation Date | 20240117 |
| Recalling Firm | ConvaTec, Inc |
| Initial Notification | Letter |
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