Class 2 Device Recall Prismaflex Control Unit

• Date Initiated by Firm: October 04, 2019
• Create Date: November 04, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0280-2020
• Recall Event ID: 83852
• 510(K)Number: K072093
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Prismaflex Control Unit, software versions below 7.21
• Code Information: Product Code: 6023014700; All Lot numbers; GTIN: 07332414073718.
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: 800-422-9837
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: Baxter Healthcare notified customers on about 10/04/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that Prismaflex Control Units with software versions 7.20 and below have the potential to produce communication errors. Instructions included that operators may continue to use the control units until the upgrade is performed, but if a communication error alarm does occur, follow the instructions presented on the graphical user interface and/or in the operators manual. It must be reinforced that it is important to manually return the extracorporeal blood to the patient, and re-train users on this process, outlined on page 10:57 of the operators manual, if necessary. A local Baxter service representative will contact your facility to determine the correction plan and schedule the software upgrade. If the affected devices was purchased from Baxter, complete the provided Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. For a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures. Questions regarding this recall can be directed to Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.
• Quantity in Commerce: 336 units
• 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, Vietnam, Canada, Argentina, Costa Rica, Cuba, Dominican Republic, Haiti, Barbados, Venezuela, St. Kitts, and EMEA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDI and Original Applicant = GAMBRO