ConvaTec Natura Stomahesive surgical ostomy system pouch-flange coupling mismatch
ConvaTec Natura Stomahesive ostomy kits contain a 45mm flange but 57mm pouch, creating an incompatible coupling. The mismatch prevents the components from fitting together properly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a functional component mismatch that prevents proper ostomy system operation. Ostomy devices are risk-of-harm medical products, and improper fit could lead to leakage and skin complications. No injuries have been reported, but the defect creates significant risk.
Plain-English summary
ConvaTec, Inc. is recalling ConvaTec Natura Stomahesive Post-Operative/Surgical Ostomy System kits, Model REF 416938, 1 3/4 in. 45mm, Sterile. The affected lot number is #2C02496. A total of 1,715 units were distributed.
The kits contain a defect in component compatibility. The flange included in the kit has a 45mm coupling ring, while the pouch is designed for a 57mm coupling ring. This mismatch prevents the pouch from fitting onto the flange, compromising the function and usability of the ostomy system.
The affected units were distributed to customers in Alaska, California, Florida, Illinois, Indiana, Michigan, Nebraska, New Jersey, New York, Ohio, Pennsylvania, and Texas, as well as to Canada.
The recalled product
- Product
- ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
- Manufacturer
- ConvaTec, Inc
- Affected units
- 1,715
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #2C02496
- UDI-DI #00768455116096.
Distribution
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