FDA-Device2018-10-10Class II
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
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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0013-2019More COVIDIEN LLC recalls
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