Recall Z-1890-2018 ยท MMH Blood Establishment Computer Software And Accessories
ConvaTec, Inc
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.
| Date | Apr 25, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 200 boxes of 10 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.