Z-0723-2023Class II

ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

Name: Z-0723-2023 ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Creator: ConvaTec, Inc
Published: 2022-11-15
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2022-11-15 / Open, Classified / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive on 2022-11-15. FDA classified it as Class II and gives the reason as "ConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0723-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-15
Posted: 2022-12-19
Recalling firm: ConvaTec Limited
Product: ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Product code: FRO Dressing, Wound, Drug
Reason for recall: ConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm issue an URGENT; VOLUNTARY MEDICAL DEVICE RECALL to its consignees by UPS Ground on 11/15/2022. The notice explained the problem and requested the following actions: "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 (Attachment 1) 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 888-364-2995. 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, HOSPITAL and EMS 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 (Attachment 1) and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory.
Quantity in commerce: 5300 devices
Distribution: US Nationwide distribution.
Product codes and lots: REF number 420861, Batch 1C03858, exp 01 Mar 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0723-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0723-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-19

Product code FRO

K123481UnclassifiedAquacel Ag Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non AdhesiveConvatec, Inc. / cleared 2013-06-06

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)