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ACTIVELIFE recallZ-0129-2023 · ConvaTec, Inc · initiated Aug 16, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

impaired functionality of the release liner

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-0129-2023
Status
Open, Classified
Initiated by the company
Aug 16, 2022
Posted by the FDA
Oct 24, 2022
Recalling firm
ConvaTec, Inc
Quantity
3209 units
Product code
EZQ
Distribution
US Nationwide distribution.

Product description

ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.

Code information (models, lots, serial numbers)

UDI/DI: 768455102891, Batch numbers: 2A03487, 2B00300

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 90856).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page