The Recall Desk
ModerateFDA (Devices)·Z-0129-2023·Announced 2022-11-02

ConvaTec Active Life Stoma Pouch Recalled for Release Liner Malfunction

ConvaTec is recalling 3,209 units of its Active Life One-Piece Drainable Pouch due to impaired functionality of the release liner. Contact the manufacturer with your batch number.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with device malfunction and no reported hospitalizations or injuries. The functional defect affects proper device operation but does not present a direct safety hazard with known harm.

Plain-English summary

ConvaTec, Inc. is recalling 3,209 units of the Active Life One-Piece Drainable Pouch (REF 400598, UDI/DI 768455102891) distributed nationwide. This one-piece pouch is designed for patients who have undergone colostomy or ileostomy procedures to manage stoma output.

The affected units have impaired functionality of the release liner, which may impact proper use of the pouch. The recall includes batch numbers 2A03487 and 2B00300.

Patients currently using this product should stop using it and contact ConvaTec, Inc. for a replacement or alternative solution. Contact the manufacturer with your batch number to confirm whether your product is affected and to obtain further assistance.

The recalled product

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.
Manufacturer
ConvaTec, Inc
Category
Medical Device — Ostomy/Stoma Care
Hazard
  • device-malfunction

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: 768455102891
  • Batch numbers: 2A03487
  • 2B00300

Distribution

Distributed nationwide across the United States.

Related recalls

Same category