DuoDERM Control Gel Formula Border Dressings recalled for incorrect packaging labeling
ConvaTec recalls DuoDERM Control Gel Formula Border Dressings due to incorrect primary packaging labeling. Lot 8G03458 (expiring July 2023) was distributed in the US and Canada.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall for incorrect primary packaging labeling with no reported illnesses or injuries. The issue qualifies as a minor labeling error per the severity rubric.
Plain-English summary
ConvaTec, Inc is recalling DuoDERM Control Gel Formula Border Dressings (15x15cm, 1x5pk) due to incorrect primary packaging labeling. Lot number 8G03458 with expiration date July 2023 is affected, comprising 170 packs.
The affected product was distributed in the United States and Canada. US states included: California, Florida, Georgia, Illinois, Maryland, Minnesota, North Carolina, New Mexico, New Jersey, Ohio, Pennsylvania, Texas, and Virginia.
The FDA classified this as a Class II recall. Consumers with the affected product should check the lot number and expiration date to determine if their product is part of this recall.
The recalled product
- Product
- DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Wound Dressing
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number 8G03458
- Expiry Jul 2023
Distribution
Distributed in 13 states:
- CA
- FL
- GA
- IL
- MD
- MN
- NC
- NJ
- NM
- OH
- PA
- TX
- VA
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