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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
Recalled October 10, 2018 · FDA recall Z-0013-2019 · COVIDIEN
Hazard
Potential for product sterility breach due to a compromised or pinched seal defect · FDA Class II
Units
2,730,821 units in total
Sold at
US Nationwide Distribution
Description
Potential for product sterility breach due to a compromised or pinched seal defect
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.
Manufacturer(s)
COVIDIEN LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →