ConvaTec AQUACEL Foam Ag Adhesive wound dressing recalled for visual contamination
ConvaTec is voluntarily recalling AQUACEL Foam Ag Adhesive wound dressings due to visual contamination (brown spots) found on several dressings. Approximately 5,300 units distributed nationwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Wound dressings are risk-of-harm products designed for direct contact with open wounds. Visual contamination presents potential infection risk. Although no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm wound dressings. The recalled batch (Reference number 420861, Batch 1C03858, expiration date March 1, 2023) contains approximately 5,300 units.
Visual contamination in the form of brown spots was identified on several dressings within this batch, prompting the voluntary recall.
The affected dressings were distributed nationwide in the United States. No illnesses or injuries have been reported.
The recalled product
- Product
- ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 5,300
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 (3)
- REF number 420861
- Batch 1C03858
- exp 01 Mar 2023
Distribution
Distributed nationwide across the United States.
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