Recall Z-1276-2024— ConvaTec, Inc
Class II · Ongoing
Class II FDA medical device recall by ConvaTec, Inc, initiated 2024-01-17. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-17
- Firm location
- Greensboro, NC, United States
Product description
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Reason for recall
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Data sourced from openFDA. This site is unofficial and independent of the FDA.