COVIDIEN Dermacea Gauze Fluff Roll Recalled for Sterility Breach Risk
COVIDIEN LLC is recalling Dermacea Gauze Fluff Rolls due to a potential seal defect that could compromise product sterility.
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: The recall involves a medical device with a risk of sterility breach, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
COVIDIEN LLC is recalling Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103. The product is used as both primary and secondary dressing for bandaging heads, limbs, and difficult-to-dress wounds. A total of 2,730,821 units were distributed nationwide in the United States.
The recall is being issued due to a potential for product sterility breach caused by a compromised or pinched seal defect. The affected lot numbers are 18D180662, 18E070362, 18E222362, and 18F072362.
Healthcare providers and consumers should stop using the affected products and contact the recalling firm for further instructions or replacement.
The recalled product
- Product
- Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Manufacturer
- COVIDIEN LLC
- Affected units
- 2,730,821
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 (4)
- Lot Numbers: 18D180662
- 18E070362
- 18E222362
- 18F072362
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by COVIDIEN LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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