ConvaTec Ostomy Pouch Recalled for Impaired Release Liner Functionality
ConvaTec is recalling 2,611 units of its Active Life ostomy pouch due to impaired release liner functionality. The defect may affect product performance and seal integrity.
What this means for you
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 an FDA Class II medical device recall for a functional defect in an ostomy management product. No injuries or illnesses have been reported, but the impaired release liner represents a risk-of-harm to users if the pouch fails to seal or attach properly.
Plain-English summary
ConvaTec, Inc. is recalling 2,611 units of its Active Life One-Piece Drainable Pouch (REF 400599, sizes 19-64mm) due to impaired functionality of the release liner. These pouches are intended for the management of stoma output following colostomy or ileostomy procedures.
The impaired release liner may compromise the product's ability to function properly. A properly functioning release liner is critical for secure attachment and seal integrity of the ostomy pouch.
The affected pouches have UDI/DI 768455102907 with batch numbers 2A03486 and 2B00301. Distribution was nationwide across the United States.
Consumers who believe they have received affected units should contact ConvaTec, Inc. with their batch number for additional guidance.
The recalled product
- Product
- ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Ostomy Pouch
- Hazard
- functional-defect
- release-liner-defect
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 (3)
- UDI/DI: 768455102907
- Batch numbers: 2A03486
- 2B00301
Distribution
Distributed nationwide across the United States.
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