Z-0018-2019 Class II Terminated
FDA device recall Z-0018-2019 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
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0018-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026