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U.S. Department of Health and Human Services

Class 2 Device Recall Dialyzer Optiflux 160NRe

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 Class 2 Device Recall Dialyzer Optiflux 160NResee related information
Date Initiated by FirmDecember 05, 2024
Date PostedJanuary 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0801-2025
Recall Event ID 95884
510(K)NumberK162488 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductDialyzer Optiflux 160NRe
Code Information UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
FEI Number 3001451489
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920
Waltham MA 02451-1521
For Additional Information ContactFresenius Medical Care Customer Service
800-323-5188
Manufacturer Reason
for Recall		Potential for internal blood leaks due to cracked polyurethane
FDA Determined
Cause 2		Process control
ActionFresenius Medical Care notified consignees on about 12/05/2024 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to stock immediately for either of the affected lot numbers, immediately discontinue use of Optiflux F160NRe Dialyzer(s) with lot codes, place any of the affected units in a secure, segregated area, arrange for return of affected product and complete and return the provided Reply Form. Additionally, consignees were instructed to forward the notification to any personnel within the organization or to customers where product was further distributed.
Quantity in Commerce5,351 cases (64,212 dialyzers)
DistributionNationwide Distribution.
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 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) Database510(K)s with Product Code = KDI
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