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U.S. Department of Health and Human Services

Class 2 Device Recall Prismaflex 7.XX

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  Class 2 Device Recall Prismaflex 7.XX see related information
Date Initiated by Firm April 24, 2018
Create Date May 23, 2018
Recall Status1 Terminated 3 on June 22, 2021
Recall Number Z-1925-2018
Recall Event ID 79965
510(K)Number K131516  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Prismaflex 7.XX US, Product Code 115269

Intended Use: The Prismaflex Control Unit is intended for: " 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. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.
Code Information All Lots and Serial Numbers
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		 Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
FDA Determined
Cause 2		 Software design
Action The firm, Baxter, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 4/24/2018 to its customers. The letter explained the reason for the recall and provided the following direction: "Operators may continue to safely use Prismaflex control units that have not exhibited the Voltage Out of Range malfunction alarm. A local Baxter service representative will contact your facility to determine the correction plan and schedule the firmware upgrade. Your facility will be receiving this firmware upgrade from Baxter at no charge. f you purchased this product directly from Baxter, complete the enclosed 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, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. If you are 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." If you have any questions, call Baxter Corporate Product Surveillance at 800-437-5176 between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday or Email Baxter at: corporate_product_complaints_round_lake@baxter.com.
Quantity in Commerce 557 units
Distribution Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominican Republic, Haiti, Barbados, Bermuda, Venezuela, Cuba, Mexico, Colombia, Brazil 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 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.
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