FDA-Device2018-10-10Class II
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.
COVIDIEN LLC
Hazard
Potential for product sterility breach due to a compromised or pinched seal defect
Sold states
US Nationwide Distribution
Affected count
2,730,821 units in total
Manufactured in
15 Hampshire St, Mansfield, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0018-2019Don't want to check this manually?
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