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Can make you unwell for a while. Do not eat it.

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 Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.

Check your package for

Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6. UDI-DI: 00840861102556. 2. Model Number: 03-5160-1. UDI-DI: 00840861102563. 3. Model Number: 03-5300-3. UDI-DI: 00840861102518. 4. Model Number: 03-5300-3C. UDI-DI: 00840861102532. 5. Model Number: 03-5350-8. UDI-DI: 00840861102525.
Why
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.
Distributed
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.
Company
Fresenius Medical Care Holdings, Inc.
Announced
Recall began
Read the official notice

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Local Recall