Device 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.
Z-1890-2018
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 79953
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 boxes of 10
- Official record key
device-enforcement:Z-1890-2018
Official wording
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.
Code information: Lot Number 7F00987
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.