ConvaTec CarboFlex Wound Dressing Recalled for Failed Sterility Standards
ConvaTec is recalling 63 market units of CarboFlex odor control dressings that fail to meet sterility assurance requirements. Affected lots were distributed in six states.
What this means for you
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: This is a risk-of-harm medical device where injury has not yet been reported. While the product fails sterility assurance standards, no illnesses, injuries, or hospitalizations have been reported.
Plain-English summary
ConvaTec, Inc. is recalling 63 market units of CarboFlex sterile odor control wound dressings (Order No. 403204, 15cm x 20cm) because the product does not meet sterility assurance level requirements.
The recalled lot numbers are 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343. The product was distributed in California, Missouri, New Mexico, Pennsylvania, Texas, and Washington.
This is a Class II FDA recall.
The recalled product
- Product
- ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Wound Dressing
- Hazard
- sterility-failure
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 (5)
- Order #403204 - Lot numbers 3J00675
- 3J02320
- 3J02332
- 3L04811
- and 4A00343.
Distribution
Distributed nationwide across the United States.
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