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 336 units of its Prismaflex Control Unit 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 due to non-restitution of blood in the extracorporeal circuit. The affected units were distributed nationwide across all U.S. states and territories, as well as internationally to countries including Australia, China, Japan, India, Korea, Singapore, Thailand, and Vietnam.
The recalled product is identified by Product Code 6023014700, all lot numbers, and GTIN 07332414073718. The source document does not specify a remedy or instructions for what affected consumers should do in response to this recall.
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: 336 units Lot/code info: Product Code: 6023014700; All Lot numbers; GTIN: 07332414073718.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.