ConvaTec, Inc ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

impaired functionality of the release liner

Recommended Action

Per FDA guidance

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