Z-0018-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- August 1, 2018
- Termination Date
- June 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,730,821 units in total
Product Description
Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 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: 18D180762,18D180862,18E029062,18E029162,18E029262, 18E029362,18E070662,18E070462,18E070562,18E130962, 18E131062,18E166462,18E166562,18E131162,18E222562, 18E222462,18F034562,18F034462,18F034362,18F072562, 18F072462,18F122462,18F122362