FDA-Device2018-05-23Class II
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.
ConvaTec, Inc
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
200 boxes of 10
Manufactured in
7900 Triad Center Dr Ste 400, Greensboro, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1890-2018Don't want to check this manually?
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