Prismaflex Control Unit, software versions below 7.21
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling Prismaflex Control Unit devices 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 resulting from non-restitution of blood in the extracorporeal circuit. A total of 988 units have been affected, identified by Product Code 114870 and GTIN 07332414115395 across all lot numbers.
The devices were distributed internationally to countries including Australia, Bangladesh, China, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan, Thailand, and Vietnam, among others. However, the devices were not distributed in the United States. The source does not specify a remedy or required consumer action.
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: 988 units Lot/code info: Product Code: 114870; All Lot numbers; GTIN: 07332414115395. Device not distributed in the US.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.