The Recall Desk
HighFDA (Devices)·Z-0128-2023·Announced 2022-11-02

ConvaTec Esteem+ Durahesive Plus Ostomy Pouch Release Liner Defect

ConvaTec recalled 182 units of Esteem+ Durahesive Plus ostomy pouches nationwide due to impaired release liner functionality. The defect affects pouches with batch number 2A02671 and UDI 768455115334.

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: FDA Class II medical device with a functional defect affecting a risk-of-harm product. Ostomy pouches are critical for patient health and hygiene; impaired release liner functionality may compromise device performance and adhesion. No reported injuries to date.

Plain-English summary

ConvaTec, Inc. recalled 182 units of Esteem+ Durahesive Plus Drainable Pouches (REF 416975, 3/4-2 1/4 inch openings, 19-64mm) due to impaired functionality of the release liner.

The recall affects pouches distributed nationwide in the United States. The defective units are identified by batch number 2A02671 and UDI/DI 768455115334.

These pouches are intended for management of stoma output following colostomy or ileostomy procedures.

The recalled product

Product
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.
Manufacturer
ConvaTec, Inc
Category
Medical Device — Ostomy Pouch
Hazard
  • product-defect
  • 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 (2)

  • UDI/DI: 768455115334
  • Batch Number: 2A02671

Distribution

Distributed nationwide across the United States.

Related recalls

Same category