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 Set; Model Number: 03-5

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 113,544 units (4,731 cases) Lot/code info: 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.

UPC codes

00840861102556, 00840861102563, 00840861102518, 00840861102532, 00840861102525

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.