Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
Reported: June 20, 2018 Initiated: May 10, 2018 #Z-2194-2018
Product Description
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
Reason for Recall
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Details
- Recalling Firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Units Affected
- 246 boxes
- 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.
- Location
- Glens Falls, NY
Frequently Asked Questions
What product was recalled? ▼
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887. Recalled by Angiodynamics Inc. (Navilyst Medical Inc.). Units affected: 246 boxes.
Why was this product recalled? ▼
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2194-2018.
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