FDA Device recall Z-0182-2020
Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
- FDA Device
- Class II
- terminated
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap by Andover Healthcare, citing incomplete packaging seal of sterile product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0182-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-19 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Andover Healthcare |
| Distribution | US |
Product
Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Reason
Incomplete packaging seal of sterile product
Identifiers
| code_info | Manufacturer's product or Catalog # 9400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI147V, CI15F1, CI17B9, CI18Y0, CI1FJ3, CI1JCF |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0182-2020%22
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