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U.S. Department of Health and Human Services

Class 2 Device Recall Prismaflex Control Unit

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  Class 2 Device Recall Prismaflex Control Unit see related information
Date Initiated by Firm February 06, 2020
Create Date April 30, 2020
Recall Status1 Terminated 3 on June 01, 2021
Recall Number Z-1828-2020
Recall Event ID 85007
510(K)Number K110823  K072093  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Prismaflex System, Prismaflex Control Unit
Code Information Product Code: 107493 GTIN 07332414073718
Recalling Firm/
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
Manufacturer Reason
for Recall
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
FDA Determined
Cause 2
Under Investigation by firm
Action Baxter is asking customers to: 1. Operators may continue to safely use the Prismaflex control unit according to the warnings and cautions in the Prismaflex Operators Manual. 2. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email.
Quantity in Commerce 4946 units
Distribution Distribution in US, Puerto Rico
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
510(K)s with Product Code = KDI and Original Applicant = GAMBRO RENAL PRODUCTS, INC.