COVIDIEN LLC recalls 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 an…

Recall date

August 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0013-2019

FDA classification

Class II

Brand / firm

COVIDIEN LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.