ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Reported: March 13, 2024 Initiated: January 17, 2024 #Z-1276-2024
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.
Details
- Recalling Firm
- ConvaTec, Inc
- Units Affected
- 1,715 units
- 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.
- Location
- Greensboro, NC
Frequently Asked Questions
What product was recalled? ▼
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.. Recalled by ConvaTec, Inc. Units affected: 1,715 units.
Why was this product recalled? ▼
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2024. Severity: Moderate. Recall number: Z-1276-2024.
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