# FDA recall Z-0504-2020

> **Angiodynamics Inc. (Navilyst Medical Inc.)** · Class II · device recall initiated 2019-09-18.

## Product

BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022

## Reason for recall

Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

## Distribution

Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.

## Key facts

- **Recall number:** Z-0504-2020
- **Recalling firm:** Angiodynamics Inc. (Navilyst Medical Inc.)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-18
- **Report date:** 2019-11-27
- **Termination date:** 2020-09-24

- **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-0504-2020

## Citation

> AI Analytics. FDA recall Z-0504-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0504-2020. Source: US FDA. Licensed CC0.

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