Recall Z-0129-2023— ConvaTec, Inc
Class II · Ongoing
Class II FDA medical device recall by ConvaTec, Inc, initiated 2022-08-16. FDA's recall record names no specific 510(k) clearance for this event. Product: ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.. Reason: impaired functionality of the release liner.
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-16
- Firm location
- Greensboro, NC, United States
Product description
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
Reason for recall
impaired functionality of the release liner
Data sourced from openFDA. This site is unofficial and independent of the FDA.