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 986 Prismaflex Control Units with software versions below 7.21 due to a hazard where communication error alarms may cause interruption of therapy, delay in therapy, or blood loss from 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, India, Japan, Korea, Singapore, Thailand, and Vietnam.
The recall covers Product Code 113081 with all lot numbers and GTIN 07332414105266. However, the source does not specify what remedy or action affected consumers should take.
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: 986 units Lot/code info: Product Code: 113081; All Lot numbers; GTIN: 07332414105266
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.