FDA-Device2018-10-10Class II

Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 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, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 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-0014-2019

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