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U.S. Department of Health and Human Services

Class 2 Device Recall Convatec Esteem(TM) Synergy Stomahesive(R),

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  Class 2 Device Recall Convatec Esteem(TM) Synergy Stomahesive(R), see related information
Date Initiated by Firm April 25, 2018
Create Date May 16, 2018
Recall Status1 Open3, Classified
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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