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.
This recall has been terminated (originally issued April 25, 2018).
- Company
- Convatec, Inc
- Recall Initiated
- April 25, 2018
- Terminated
- February 27, 2023
- Recall Number
- Z-1890-2018
- Quantity
- 200 boxes of 10
- Firm Location
- Greensboro, NC
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot Number 7F00987
Root Cause
Process control
Action Taken
ConvaTec sent an Urgent Voluntary Medical Device Recall dated April 20, 2018. Customers were directed to inspect their inventory, perform a count of affected product, and respond even if none of the recalled product was found. Once the response is received, return instructions will be provided. Distributors were directed to perform a sub-account recall, forwarding the letter to their customers. The firm will be providing replacement product.