COVIDIEN Dermacea Gauze Fluff Rolls Recalled for Sterility Breach Risk
COVIDIEN LLC is recalling Dermacea Gauze Fluff Rolls due to a potential seal defect that could compromise 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 poses a risk of harm (infection) even though specific injuries or illnesses have not been reported in the source text.
Plain-English summary
COVIDIEN LLC is recalling Dermacea Gauze Fluff Rolls, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106. The recall involves 2,730,821 units distributed nationwide in the United States. The product is used as both primary and secondary dressing for bandaging heads, limbs, and difficult-to-dress wounds.
The recall was initiated due to a potential for product sterility breach caused by a compromised or pinched seal defect. This defect could allow contamination of the sterile dressing material.
Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the supplier or the manufacturer for credit or replacement.
The recalled product
- Product
- Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Manufacturer
- COVIDIEN LLC
- Category
- Medical Device — Wound Dressing
- 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 (20)
- Lot Numbers: 18D180762
- 18D180862
- 18E029062
- 18E029162
- 18E029262
- 18E029362
- 18E070662
- 18E070462
- 18E070562
- 18E130962
- 18E131062
- 18E166462
- 18E166562
- 18E131162
- 18E222562
- 18E222462
- 18F034562
- 18F034462
- 18F034362
- 18F072562
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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