FDA Device recall Z-0017-2019
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…
- 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, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing… 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-0017-2019 |
| 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, 4-1/2 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.
Reason
Potential for product sterility breach due to a compromised or pinched seal defect
Identifiers
| code_info | Lot Numbers: 18D180662,18E070362,18E222362,18F072362 |
|---|
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-0017-2019%22
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