ConvaTec, Inc 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
ConvaTec, Inc
Lot Codes / Batch Numbers
Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.
Products Sold
Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.
ConvaTec, Inc is recalling ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. P due to The product does not meet sterility assurance level.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product does not meet sterility assurance level.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026