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U.S. Department of Health and Human Services

Class 2 Device Recall Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

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  Class 2 Device Recall Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E see related information
Date Initiated by Firm November 05, 2018
Create Date December 21, 2018
Recall Status1 Open3, Classified
Recall Number Z-0658-2019
Recall Event ID 81598
510(K)Number K152367  K162488  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Code Information Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019 
Recalling Firm/
Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact Fresenius Medical Care Customer Service
800-323-5188
Manufacturer Reason
for Recall
Potential for external blood leaks from the dialyzer header
FDA Determined
Cause 2
Other
Action On November 6, 2018, Fresenius Medical Care issued URGENT MEDICAL DEVICE RECALL notices to customers. Customers were advised to take the following actions: 1. Check your inventory for the affected lot numbers. 2. If found, discontinue use of these lots. 3. Please all affected units in a secure, segregated area. 4. Contact Stericycle at 1-888-731-7986 for instructions on how to return the recalled product or if replacement product is needed right away. (Refer to EVENT # 6273). 5. Complete and return the Reply Form. Customers with questions may contact Medical Information and Communications at 855-616-2309 or thru the website www.fresenius-medinfo.com.
Quantity in Commerce 9,097 cs x 12 units each
Distribution US Nationwide
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 = FRESENIUS MEDICAL CARE NORTH AMERICA
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