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Fresenius Medical Care Holdings, Inc.: 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing

Medical DevicesSource: FDA (device) · Date: 2026-07-15

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Fresenius Medical Care Holdings, Inc.
Product
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 3. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 4. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
Reason / hazard
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.
Recall initiated
2026-05-11
Code info
Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6; UDI-DI: 00840861102556; Lot Number: 26BR01177. 2. Model Number: 03-5300-3; UDI-DI: 00840861102518; Lot Numbers: 26BR01184, 26BR01202, 26CR01025, 26CR01039, 26CR01803, 26BR01185, 26BR01214, 26CR01026, 26CR01040, 26CR01804, 26BR01188, 26BR01215, 26CR01027, 26CR01041, 26DR01134, 26BR01189, 26BR01805, 26CR01029, 26CR01043, 26BR01201, 26CR01003, 26CR01034, 26CR01800. 3. Model Number: 03-5300-3C; UDI-DI: 00840861102532; Lot Numbers: 26CR01018, 26CR01020, 26DR01129, 26DR01150, 26CR01019, 26CR01021, 26DR01130, 26DR01151. 4. Model Number: 03-5350-8; UDI-DI: 00840861102525; Lot Numbers: 26CR01017, 26DR01077, 26DR01079, 26DR01080.
Product quantity
113,544 units (4,731 cases)
Voluntary mandated
Voluntary: Firm initiated
City
Waltham
State
MA
Country
United States
Event id
99061
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