Official recall notice
Blood Tubing Set Recall (Jul 2026)
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 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.
- Recall date
- 2026-07-15
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
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.