FDA recall Z-0318-2022

Product

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

Reason for recall

Due to an uptick of complaints associated with premature needle retraction of blood collection system.

Distribution

U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.

Key facts

Status

Terminated

Initiation date

2021-11-02

Report date

2021-12-08

Termination date

2023-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Seattle, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0318-2022