Z-2614-2021Class II

DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

Name: Z-2614-2021 DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Creator: ConvaTec, Inc
Published: 2021-08-20
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2021-08-20 / Open, Classified / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) on 2021-08-20. FDA classified it as Class II and gives the reason as "Primary packaging labeling may be incorrect". 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-2614-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-20
Posted: 2021-09-30
Recalling firm: ConvaTec Limited
Product: DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Product code: NAD Dressing, Wound, Occlusive
Reason for recall: Primary packaging labeling may be incorrect.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Consignees are notified of the recall via email and letter delivered via UPS. The recalling firm identifies Tier 1 customers as direct consignees and Tier 2 customers and those who receive product from Tier 1 customers. Impacted customers that identify affected product within their inventory are to arrange for return of product through third party Sedgwick.
Quantity in commerce: 170 packs
Distribution: Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA
Product codes and lots: Lot Number 8G03458, Expiry Jul 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2614-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2614-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-30

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)