Device product
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.
Z-0016-2019
Product summary
- Firm
- COVIDIEN LLC
- Event
- Event 80924
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,730,821 units in total
- Official record key
device-enforcement:Z-0016-2019
Official wording
Reason: Potential for product sterility breach due to a compromised or pinched seal defect
Code information: Lot Numbers: 18E071762,18E072262,18E072362,18E132262,18E132362
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Sterility assurance
sterility breach due to a compromised or pinched seal defect