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Recall Observatory FDA recall evidence

Device 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.

Z-0013-2019

August 01, 2018

Class II

Product summary

Firm
COVIDIEN LLC
Event
Event 80924
Status
Terminated
Classification
Class II
Quantity
2,730,821 units in total
Official record key
device-enforcement:Z-0013-2019

Official wording

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

Code information: 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

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility breach due to a compromised or pinched seal defect