# FDA recall Z-0076-2019

> **Angiodynamics Inc. (Navilyst Medical Inc.)** · Class II · device recall initiated 2018-07-24.

## 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

## Distribution

US Nationwide in the state of IN.

## Key facts

- **Recall number:** Z-0076-2019
- **Recalling firm:** Angiodynamics Inc. (Navilyst Medical Inc.)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-24
- **Report date:** 2018-10-17
- **Termination date:** 2019-05-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glens Falls, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0076-2019

## Citation

> AI Analytics. FDA recall Z-0076-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0076-2019. Source: US FDA. Licensed CC0.

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