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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 Unitsee related information
Date Initiated by FirmFebruary 06, 2020
Create DateApril 30, 2020
Recall Status1 Terminated 3 on June 01, 2021
Recall NumberZ-1829-2020
Recall Event ID 85007
510(K)NumberK072093 K110823 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductPrismaflex System, Prismaflex Control Unit
Code Information Product Code: 113081; GTIN 07332414105266
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
847-948-4770
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
ActionBaxter 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 Commerce1225 units
DistributionDistribution in US, Puerto Rico
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KDI
510(K)s with Product Code = KDI
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