Z-1495-2024Class II

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

Name: Z-1495-2024 ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1...
Creator: ConvaTec, Inc
Published: 2024-02-27
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2024-02-27 / Open, Classified / root cause: sterility

FDA source

ConvaTec, Inc began a recall of ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit on 2024-02-27. FDA classified it as Class II and gives the reason as "The product does not meet sterility assurance level". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1495-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-27
Posted: 2024-04-08
Recalling firm: ConvaTec Limited
Product: ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
Product code: NAC Dressing, Wound, Hydrophilic
Reason for recall: The product does not meet sterility assurance level.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 63 market units
Distribution: US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
Product codes and lots: Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1495-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1495-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-08

Product code NAC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)