ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/im

FDA device recall Z-1495-2024 · posted 2024-04-08 · Open, Classified

Recall details

Recalling firm

ConvaTec, Inc

Reason for recall

The product does not meet sterility assurance level.

Action taken

The recalling firm issued letters dated Feb-2024 via email on 2/27/2024 listing all product and serial numbers that were distributed worldwide. The letter explained the issue and the associated hazard and potential risk to the end user. The addressee was instructed to immediately examine their inventory and quarantine the affected product. If the product was further distributed, the consignee was requested to identify their customers of the recall at once and notify them. The recall was to be conducted to the end-user level. The enclosed response form was to be returned within 30 calendar days of receipt of the letter. Once the response form has been returned, the recalling firm will provide the consignee with a Certificate of Destruction for completion and the affected product is then to be immediately destroyed. Once the Certificate of Destruction is returned, the consignee will be credited.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NAC

Quantity affected

63 market units

Distribution

US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.

Date initiated

2024-02-27

Date posted

2024-04-08

Location

Greensboro, NC