FDA recall Z-1890-2018

Product

Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.

Reason for recall

It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-04-25

Report date

2018-05-23

Termination date

2023-02-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greensboro, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1890-2018