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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 0500316Esee related information
Date Initiated by FirmNovember 05, 2018
Create DateDecember 21, 2018
Recall Status1 Terminated 3 on April 17, 2023
Recall NumberZ-0658-2019
Recall Event ID 81598
510(K)NumberK152367 K162488 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductOptiflux 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 ContactFresenius 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
ActionOn 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 Commerce9,097 cs x 12 units each
DistributionUS Nationwide
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
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