Baxter Healthcare Corporation: Medical Device Recall in 2019 - (Recall #: Z-0277-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Prismaflex Control Unit, software versions below 7.21

Product Classification:

Class II

Date Initiated: October 4, 2019

Date Posted: November 13, 2019

Recall Number: Z-0277-2020

Event ID: 83852

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.

Status: Ongoing

Product Quantity: 986 units

Code Information:

Product Code: 113081; All Lot numbers; GTIN: 07332414105266

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated