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U.S. Department of Health and Human Services

Class 2 Device Recall 5008X Standard HD PreFlush Standard Blood Tubing Set

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 Class 2 Device Recall 5008X Standard HD PreFlush Standard Blood Tubing Setsee related information
Date Initiated by FirmAugust 10, 2026
Date PostedSeptember 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3084-2026
Recall Event ID 99556
510(K)NumberK243505 
Product Classification Accessories, blood circuit, hemodialysis - Product Code KOC
Product5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Code Information Lots 25KR01227 25NR01257 UDI-DI 00840861102556
FEI Number 3001451489
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St Bld 920
Waltham MA 02451-1521
For Additional Information ContactFresenius Medical Care Customer Service
800-323-5188
Manufacturer Reason
for Recall		Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
FDA Determined
Cause 2		Component change control
ActionOn 8/10/2026, the firm began notifying consignees via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to 1. Identify any affected product on hand. 2. IMMEDIATELY segregate and discontinue use of affected lot. 3. Contact the call center at 1-888-943-4901 and reference Event 8514, between 8:00 AM 4:30 PM Eastern daily, for return of affected lots and replacement of your stock. 4, Complete and return the included reply form.
Quantity in Commerce120 units
DistributionWorldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.
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 = KOC
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