FDA recall Z-0127-2023

Product

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.

Reason for recall

impaired functionality of the release liner

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2022-08-16

Report date

2022-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greensboro, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2023