FDA Device recall Z-0013-2019
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…
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of 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… by Covidien, citing potential for product sterility breach due to a compromised or pinched seal defect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0013-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-01 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
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
Potential for product sterility breach due to a compromised or pinched seal defect
Identifiers
| code_info | Lot Numbers: 18D180962,18D181062,18E029462,18E029562,18E070762, 18E131262,18E131362,18E131462,18E166662,18E167362, 1…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0013-2019%22
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