FDAFDA · Food and drugs·Recall number Z-0129-2023
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.
Published November 2, 2022 · Recall initiated: August 16, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
impaired functionality of the release liner
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ConvaTec, Inc
- Distributor
- US Nationwide distribution.
- Lot
- UDI/DI: 768455102891, Batch numbers: 2A03487, 2B00300
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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