Device product
Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019
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-0017-2019
Official wording
Reason: Potential for product sterility breach due to a compromised or pinched seal defect
Code information: Lot Numbers: 18D180662,18E070362,18E222362,18F072362
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Sterility assurance
sterility breach due to a compromised or pinched seal defect