Prismaflex Control Unit, software versions below 7.21
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation has recalled Prismaflex Control Units with software versions below 7.21 due to a hazard involving communication error alarms. These alarms may cause interruption of therapy, delay in therapy, or blood loss when blood is not returned to the patient from the extracorporeal circuit. The affected units were distributed nationwide across all U.S. states and territories, as well as internationally to multiple countries in Asia and Oceania. A total of 2,760 units with Product Code 107493 and all associated lot numbers are involved.
The source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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, Viet Quantity: 2,760 units Lot/code info: Product Code: 107493; All Lot numbers; GTIN: 07332414073718
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.