FDA Device recall Z-0076-2019
BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED
- FDA Device
- Class II
- terminated
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class II recall of BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED by Angiodynamics Navilyst Medical, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0076-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-24 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | US |
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
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
Identifiers
| code_info | Lot Number: 5363172 |
|---|
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-0076-2019%22
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