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U.S. Department of Health and Human Services

Class 2 Device Recall Optiflux 200NRe Dialyzer

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  Class 2 Device Recall Optiflux 200NRe Dialyzer see related information
Date Initiated by Firm May 04, 2022
Create Date June 30, 2022
Recall Status1 Terminated 3 on May 06, 2024
Recall Number Z-1303-2022
Recall Event ID 90367
510(K)Number K162488  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Code Information UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information Contact Fresenius Medical Care Customer Service
800-323-5188
Manufacturer Reason
for Recall
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
FDA Determined
Cause 2
Under Investigation by firm
Action A Customer Notification was sent to the five (5) affected consignees on 05/04/2022 via USPS First Class Mail. The firm also followed up with phone calls with consignees with instructions to examine their stock to determine whether they have affected product on hand, and to remove product from their inventory.
Quantity in Commerce 19 cases
Distribution US Nationwide distribution in the state of Pennsylvania.
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 = FRESENIUS MEDICAL CARE NORTH AMERICA
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