Consumer Alerts TrackerIndependent U.S. recall decision aid
How it works Search recalls
Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 15, 2026

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

Full official product description

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.

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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.

Identifiers to compare

  • UDI 00840861102556
  • UDI 00840861102563
  • UDI 00840861102518
  • UDI 00840861102532
  • UDI 00840861102525
  • Model numbers
  • Model 03-5110-6
  • Model 03-5160-1
  • Model 03-5300-3
  • Model 03-5300-3C
  • Model 03-5350-8
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
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:...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: 00840861102525.113,544 units (4,731 cases)Z-2702-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.