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 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 due to non-restitution of blood in the extracorporeal circuit. The recall affects 1,014 units 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 affected Prismaflex Control Units are identified by Product Code 115269 (GTIN: 07332414117702) and Product Code 955542 (GTIN: 07332414124236), with all lot numbers included in the recall. The source does not specify a remedy or corrective 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: 1,014 units Lot/code info: Product Code: 115269 (GTIN: 07332414117702), 955542 GTIN: 07332414124236); All Lot numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.