medical Class II Updated 2018-10-10

COVIDIEN LLC recalls Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (

Recalled Product

Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

Hazard / Issue

Potential for product sterility breach due to a compromised or pinched seal defect

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Lot Numbers: 18D180962,18D181062,18E029462,18E029562,18E070762, 18E131262,18E131362,18E131462,18E166662,18E167362, 18E223462,18E223362,18F054362,18E222662,18F034762, 18F034662,18F035562,18F072862,18F072662,18F072962, 18F123062,18F122562,18F122662

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