PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: November 2, 2022 Initiated: August 16, 2022 #Z-0128-2023

Product Description

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.

Reason for Recall

impaired functionality of the release liner

Details

Recalling Firm
ConvaTec, Inc
Units Affected
182 units
Distribution
US Nationwide distribution.
Location
Greensboro, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by ConvaTec, Inc. Units affected: 182 units.
Why was this product recalled?
impaired functionality of the release liner
Which agency issued this recall?
This recall was issued by the FDA Devices on November 2, 2022. Severity: Moderate. Recall number: Z-0128-2023.