# FDA recall Z-2395-2020

> **Angiodynamics, Inc.** · Class II · device recall initiated 2020-05-04.

## Product

BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature.    Item Numbers  H965460151  H965460161  H965460161-NP  H965460171  H965460181  H965460221  H965460231  H965460241  H965460251  H965460261  H965460271  H965460281  H965460291  H965464601  H965464701  H965464701-NP  H965464801  H965464901    Cat. No.   46-015  46-016  46-016-NP  46-017  46-018  46-022  46-023  46-024  46-025  46-026  46-027  46-028  46-029  46-460  46-470  46-480  46-490

## Reason for recall

Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2395-2020
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-04
- **Report date:** 2020-06-24
- **Termination date:** 2023-08-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2395-2020

## Citation

> AI Analytics. FDA recall Z-2395-2020. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2395-2020. Source: US FDA. Licensed CC0.

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