ConvaTec Natura Stomahesive Post-Operative / Surgical recall
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Why was ConvaTec Natura Stomahesive Post-Operative / Surgical recalled?
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #2C02496, UDI-DI #00768455116096.
- Product
- ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
- Recalling firm
- ConvaTec, Inc
- Quantity
- 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.
- Recall date
- March 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)