Class 2 Device Recall Prismaflex Control Unit

• Date Initiated by Firm: February 15, 2017
• Create Date: March 30, 2018
• Recall Status: Terminated on May 08, 2019
• Recall Number: Z-1280-2018
• Recall Event ID: 76464
• 510(K)Number: K110823
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system.; ; Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
• Code Information: Product code: 6023014700, 107493, 113081, 115269; Serial Number: All; Affected Software Versions: SW 4.1x, 5.10, 6.10, 7.xx, 8.00
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.
• FDA Determined Cause: Use error
• Action: On February 15, 2017, the firm sent an Urgent Device Correction notification and response form to affected customers via USPS first class mail in order to update software versions of the Prismaflex Control Units. The update was intended to prevent user errors related to the safe unloading of disposable sets. On May 30, 2017, the firm issued an updated notification letter notifying the same customer base of the issue with the programmed syringe sizes. The software update deployed to correct the issue with the safe unloading of disposable sets was also deployed to correct the issue with the programmed syringe sizes. All non-responding customers will be contacted via telephone. Prismaflex control units will be updated to a new software version. For further questions, please call (800) 422-9837.
• Quantity in Commerce: 3,440 units
• Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Algeria, Armenia, Australia, Bahrain, Belarus, Belgium, Canada, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Ireland, Italy, Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, Iceland, India, Iran, Israel, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Montenegro, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Ukraine, Vietnam, Yemen, Argentina, Brazil, Chile, and Dominican Republic
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KDI and Original Applicant = GAMBRO RENAL PRODUCTS, INC.