Sterile Co-Flex LF2 3" — Class II medical device recall Z-0181-2020
Terminated recall by Andover Healthcare Inc., reported 2019-10-30, distributed nationwide. Incomplete packaging seal of sterile product
| Recall number | Z-0181-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Andover Healthcare Inc., Salisbury, MA, United States |
| Recall initiated | 2019-06-19 |
| Classified | 2019-10-23 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2020-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 330 cases |
| Reason classes | sterility, packaging |
| Model numbers | 14JUN2022, 9300S |
| Expiration dates | 2021-10-01 |
Product
Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
Reason for recall
Incomplete packaging seal of sterile product
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0181-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.