BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F… — Class II medical device recall Z-0076-2019
Terminated recall by Angiodynamics Inc. (Navilyst Medical Inc.), reported 2018-10-17, distributed nationwide. BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port asse
| Recall number | Z-0076-2019 |
|---|---|
| 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 | 2018-07-24 |
| Classified | 2018-10-05 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2019-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 1 boxes |
| Reason classes | sterility |
| Lot numbers | 5363172 |
| Model numbers | 44-021 |
Product
BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
Reason for recall
BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled
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-0076-2019. 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.