Kerlix AMD Antimicrobial Bandage Roll — Class II medical device recall Z-0013-2019
Terminated recall by COVIDIEN LLC, reported 2018-10-10, distributed nationwide. Potential for product sterility breach due to a compromised or pinched seal defect
| Recall number | Z-0013-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN LLC, Mansfield, MA, United States |
| Recall initiated | 2018-08-01 |
| Classified | 2018-10-02 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2020-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 2,730,821 units |
| Reason classes | sterility, packaging |
| Lot numbers | 18D180962, 18D181062, 18E029462, 18E029562, 18E070762, 18E131262, 18E131362, 18E131462, 18E166662, 18E167362, 18E222662, 18E223362, 18E223462, 18F034662, 18F034762, 18F035562, 18F054362, 18F072662, 18F072862, 18F072962, 18F122562, 18F122662, 18F123062 |
| Model numbers | 3332 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0013-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.