FDA-Device2018-10-10Class II
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 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
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 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-0016-2019Don't want to check this manually?
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