FDA recall Z-0277-2020

Product

Prismaflex Control Unit, software versions below 7.21

Reason for recall

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

Distribution

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. International distribution to Australia, Bangladesh, Brunei, China, Hongkong, Indonesia, India, Japan, New Zealand, Taiwan, Korea, Singapore, Malaysia, Macau, Thailand, Vietnam, Canada, Argentina, Costa Rica, Cuba, Dominican Republic, Haiti, Barbados, Venezuela, St. Kitts, and EMEA.

Key facts

Status

Ongoing

Initiation date

2019-10-04

Report date

2019-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2020