FDA recall Z-2195-2018

Product

Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2195-2018