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U.S. Department of Health and Human Services

Class 2 Device Recall Prismaflex HF

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  Class 2 Device Recall Prismaflex HF see related information
Date Initiated by Firm July 22, 2021
Create Date August 27, 2021
Recall Status1 Open3, Classified
Recall Number Z-2379-2021
Recall Event ID 88351
510(K)Number K042938  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Baxter prismaflex, HF 1000 PAES membrane, REF 107140

Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Code Information Lot Numbers: 20B2330M
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
Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming
FDA Determined
Cause 2
Vendor change control
Action The firm notified its consignees of the recall by letter on 07/22/2021. The letter explained the issue and requested the return of the affected product. Distributors were directed to notified their consignees.
Quantity in Commerce 1976 units
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = GAMBRO RENAL PRODUCTS
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