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U.S. Department of Health and Human Services

Class 2 Device Recall ConvaTec

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  Class 2 Device Recall ConvaTec see related information
Date Initiated by Firm August 16, 2022
Date Posted October 24, 2022
Recall Status1 Open3, Classified
Recall Number Z-0128-2023
Recall Event ID 90856
Product Classification Pouch, colostomy - Product Code EZQ
Product ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975.
For the management of stoma output following a colostomy or ileostomy procedure.
Code Information UDI/DI: 768455115334, Batch Number: 2A02671
Recalling Firm/
Manufacturer		 ConvaTec, Inc
7815 National Service Rd Ste 600
Greensboro NC 27409-9403
Manufacturer Reason
for Recall		 impaired functionality of the release liner
FDA Determined
Cause 2		 Under Investigation by firm
Action Convatec issued an Urgent: Voluntary Medical Device Recall notice on 09/16/2022 by mail. The notice explained the reason for the recall and requested the following actions be taken: "DISTRIBUTOR ACTIONS: 1 Immediately stop distributing and quarantine all recalled lots. 2 Perform a count of recalled product currently in inventory. Complete the enclosed response form and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory. 3 Call toll free number (to be assigned). You will be assigned an RGA number and given instructions on how to return the recalled product. Recalled product must be returned in a separate container from any other product returns. 4 Mark all return shipments Recalled Product and provide the supplied RGA number. 5 Product must be labeled for shipment to: Sedgwick, 2670 Executive Drive, Suite A, Indianapolis, IN, 46241, U.S.A. 6 Your account will be credited for all returned product. Please ensure your account number is correctly identified on the attached Recall Response Form. 7 If you have distributed this product to other wholesalers then forward this letter to them and ask that they follow these Distributor Actions and return the attached Recall Response Form to the address listed on the form. 8 Send a copy of this recall package to all other consignees: Retailers, if applicable, and end users. It is extremely important to identify the responsible individual, who is in charge of recall activities, at hospital locations. This will make the recall process more effective and eliminate confusion and duplicated effort." "RETAILER ACTIONS: 1 Immediately stop distributing and quarantine all recalled lots. 2 Perform a count of recalled product currently in inventory. Complete the enclosed response form and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory. It is important that you send a cop
Quantity in Commerce 182 units
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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