Z-0013-2019 Class II Terminated
FDA device recall Z-0013-2019 was initiated by COVIDIEN LLC on Aug 1, 2018 and is designated Class II. Reason for recall: Potential for product sterility breach due to a compromised or pinched seal defect The recall status is terminated (terminated Jun 3, 2020). Affected quantity: 2,730,821 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- Aug 1, 2018
- Termination Date
- Jun 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,730,821 units in total
Product Description
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 Pattern
US Nationwide Distribution
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0013-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026