DuoDerm Sealing defect (2021-08-20)
Brand(s)
Last updated
Summary
Product
DuoDerm Sealing defect (2021-08-20)
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or Serial Number | Model or catalog number |
|---|---|---|
| DUODERM CGF - CONTROL GEL FORMULA DRESSING | 9B02984Y | 187660 |
| DUODERM EXTRA THIN CGF DRESSING | 9H04865, 9L02456, 9L04890 | 187955, 187957 |
Issue
An increase in complaints related to incomplete seals or the dressing been trapped in packaging was observed. As a potential hazard associated with these complaints involve the dressing being open or the product being sealed within the same primary package, there is a possible risk of infection. Delayed wound healing and increased scarring.
Recall start date: Sep 2, 2021
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
CONVATEC INC.
7815 National Service Road, Suite 600, Greensboro, North Carolina
US, 27409
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-62823
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