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.
Other recalls by Angiodynamics Navilyst Medical
- Xcela PICC with PASV Valve Technology/Kit 5 F-55cm
FDA Device · Class II · 2021-10-06 · Angiodynamics Navilyst Medical - AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of va…
FDA Device · Class II · 2021-04-28 · Angiodynamics Navilyst Medical - Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access o…
FDA Device · Class II · 2021-04-28 · Angiodynamics Navilyst Medical - XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical - BIOFLO 8F SINGLE PLASTIC FILLED
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical
All Angiodynamics Navilyst Medical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0076-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.