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ConvaTec, Inc recalls Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive wit
Recalled May 23, 2018 · FDA recall Z-1890-2018 · ConvaTec
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. · FDA Class II
Units
200 boxes of 10
Sold at
US Nationwide Distribution
Description
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.
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.
Manufacturer(s)
ConvaTec, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →