Recall Z-0128-2023 ยท EZQ Pouch, Colostomy
ConvaTec, Inc
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.
| Date | Oct 24, 2022 (initiated Aug 16, 2022) |
| Status | Open, Classified |
| Reason | impaired functionality of the release liner |
| Root cause | 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 inst |
| Quantity | 182 units |
| 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.