Recall Z-1890-2018— ConvaTec, Inc
Class II · Terminated
Class II FDA medical device recall by ConvaTec, Inc, initiated 2018-04-25, terminated 2023-02-27. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-25
- Terminated
- 2023-02-27
- Firm location
- Greensboro, NC, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.