FDA recall Z-0013-2019

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.

Reason for recall

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

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-08-01

Report date

2018-10-10

Termination date

2020-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0013-2019