Z-0014-2019 Class II Terminated
FDA device recall Z-0014-2019 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 Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
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: 18D181262,18D181162,18E029662,18E029762,18E029862, 18E029962,18E030062,18E030162,18E030262,18E030362, 18E070962,18E071062,18E071162,18E071262,18E071362, 18E071462,18E071562,18E071662,18E131562,18E131962, 18E132062,18E132162,18E131662,18E131762,18E131862, 18E166762,18E167462,18E166862,18E166962,18E167562, 18E167162,18E167062,18E167762,18E167662,18E167262, 18E222762,18E223162,18E223062,18E222962,18E222862, 18E223662,18E223562,18E224062,18E223962,18E223862, 18E223762,18F035862,18F034962,18F034862,18F035262, 18F035162,18F035062,18F035362,18F035962,18F035762, 18F035462,18F089262,18F036262,18F036162,18F036062, 18F073062,18F072762,18F123262,18F123162,18F158462, 18F158362,18G004562
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0014-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026