Z-0016-2019 Class II Terminated
FDA device recall Z-0016-2019 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, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 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: 18E071762,18E072262,18E072362,18E132262,18E132362
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0016-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026