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U.S. Department of Health and Human Services

Class 2 Device Recall Prismaflex System

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  Class 2 Device Recall Prismaflex System see related information
Date Initiated by Firm April 07, 2020
Create Date May 21, 2020
Recall Status1 Terminated 3 on November 09, 2021
Recall Number Z-2066-2020
Recall Event ID 85405
510(K)Number K131516  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Prismaflex Control Unit
Code Information Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact
800-422-9837
Manufacturer Reason
for Recall		 Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
FDA Determined
Cause 2		 Under Investigation by firm
Action Baxter notified customers on about 04/07/2020 via "URGENT MEDICAL DEVICE RECALL" letter. The letter instructed customers that the affected units can still be used until the replacement is performed, a local Baxter representative will contact each facility to schedule the replacement of affected devices, complete and return the Baxter Customer Reply Form by scanning and e-mailing it to perezd2@baxter.com, and if the affected devices have been further distributed, to please notify those customers by forwarding a copy of the recall notification. For general questions, contact Baxter Customer Service at 787 866 70 27, between the hours of 7:00 am to 4:00 pm local time, Monday through Friday.
Quantity in Commerce 5 devices US territories
Distribution Distribution only to Puerto Rico and Guam
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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