FDA Medical Device Recalls (openFDA)
ConvaTec, Inc: DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
- Recall number
- Z-2614-2021
- Recalling firm
- ConvaTec, Inc
- Product
- DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
- Status
- Open, Classified
- Initiated
- 2021-08-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- Primary packaging labeling may be incorrect.
- 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
- 170 packs
- Distribution
- Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA
- Lot, serial or model codes
- Lot Number 8G03458, Expiry Jul 2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAD
- Firm FEI
- 3011987967
- Firm city
- Greensboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28