# FDA recall Z-2202-2018

> **Angiodynamics Inc. (Navilyst Medical Inc.)** · Class II · device recall initiated 2018-05-10.

## Product

RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472

## Reason for recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

## Distribution

The products were distributed to the following US states:  AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV.  The products were distributed to the following foreign countries:  Canada, China, Ireland, Spain.

## Key facts

- **Recall number:** Z-2202-2018
- **Recalling firm:** Angiodynamics Inc. (Navilyst Medical Inc.)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-10
- **Report date:** 2018-06-20
- **Termination date:** 2020-05-13

- **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-2202-2018

## Citation

> AI Analytics. FDA recall Z-2202-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2202-2018. Source: US FDA. Licensed CC0.

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