FDA Device recall Z-0018-2019
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…
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of 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… by Covidien, citing potential for product sterility breach due to a compromised or pinched seal defect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0018-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-01 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
Product
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
Potential for product sterility breach due to a compromised or pinched seal defect
Identifiers
| code_info | Lot Numbers: 18D180762,18D180862,18E029062,18E029162,18E029262, 18E029362,18E070662,18E070462,18E070562,18E130962, 1…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0018-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.