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COVIDIEN LLC recalls 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
Recalled October 10, 2018 · FDA recall Z-0018-2019 · COVIDIEN
Hazard
Potential for product sterility breach due to a compromised or pinched seal defect · FDA Class II
Units
2,730,821 units in total
Sold at
US Nationwide Distribution
Description
Potential for product sterility breach due to a compromised or pinched seal defect
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(s)
COVIDIEN LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →