Date Initiated by Firm | April 25, 2018 |
Create Date | May 16, 2018 |
Recall Status1 |
Terminated 3 on February 27, 2023 |
Recall Number | Z-1890-2018 |
Recall Event ID |
79953 |
Product Classification |
Blood Establishment Computer Software and Accessories - Product Code MMH
|
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. |
Code Information |
Lot Number 7F00987 |
Recalling Firm/ Manufacturer |
ConvaTec, Inc 7900 Triad Center Dr Ste 400 Greensboro NC 27409-9076
|
For Additional Information Contact | mediarelations@convatec.com 336-547-3730 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 200 boxes of 10 |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|