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
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
sterility breach due to a compromised or pinched seal defect