Z-2519-2021Class II

DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957)...

Name: Z-2519-2021 DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957)...
Creator: ConvaTec, Inc
Published: 2021-08-09
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2021-08-09 / Open, Classified / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC... on 2021-08-09. FDA classified it as Class II and gives the reason as "There is a potential for open seals which can compromise sterility". 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-2519-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-09
Posted: 2021-09-23
Recalling firm: ConvaTec Limited
Product: DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
Product code: NAD Dressing, Wound, Occlusive
Reason for recall: There is a potential for open seals which can compromise sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customer notification was made via email and via UPS letter. Distributors are asked to stop distributing and quarantine all recalled lots. All customers are notified that a Recall Response Form is to be completed and returned to the recalling firm. All impacted product is to be returned via third party Sedgwick, Indianapolis, IN. If product was further distributed, the customer shall forward the recall notification letter and ask subaccounts to follow the recall instructions.
Quantity in commerce: 2,734,830 units
Distribution: International distribution to the countries of Argentina, Aruba, Australia, Bonaire, Brazil, Canada, Chile, , Colombia, Costa Rica, Curaco, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Indonesia, Iran, Malaysia, Mexico, Myanmar, Nicaragua, New Zealand, Panama, Peru, , Pakistan, Paraguay, Qatar, Singapore, South Korea, Switzerland, Taiwan, Thailand, UAE, Uruguay, USA and Vietnam.
Product codes and lots: ICC 187660 - Lots 9B02984Y, 9G04308, 9K05775, 9L00556, 0A03460, and 9A04124Y ICC 187957 - Lots 9J02859, 9H02226, 9H04865, 9L02456 ICC 187955 - Lots 9L01731, 9L04890, 9K02656, 9H01234, 9M01779, and 9H00183

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2519-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2519-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-23

Product code NAD

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)