BIOFLO 8F SINGLE PLASTIC FILLED — Class II medical device recall Z-0504-2020
Terminated recall by Angiodynamics Inc. (Navilyst Medical Inc.), reported 2019-11-27, distributed nationwide. Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the ca
| Recall number | Z-0504-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY, United States |
| Recall initiated | 2019-09-18 |
| Classified | 2019-11-21 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2020-09-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 582 |
| Model numbers | 44-022 |
Product
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Reason for recall
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
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-0504-2020. 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.