HIGH

Baxter Healthcare Recalls Continu-Flo Solution Set Over Tubing Separation Hazard

Baxter Healthcare Corporation recalled 14,400 units of its Continu-Flo solution set on August 8, 2025. The recall follows customer reports of tubing separation that pose serious risks. Healthcare providers and patients must stop using the device immediately.

Hazard Information

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions. Notification method: Letter

Product Details

The Continu-Flo solution set features two Clearlink Luer activated valves and a backcheck valve. It has a length of 112 inches (2.8 m) and is identified by product code REF 2C8519.

The Hazard

The tubing separation can lead to serious complications during intravascular administration. This recall has been classified as Class II, indicating a potential risk of injury.

Reported Incidents

Baxter received multiple reports of tubing separation, but specific incident counts have not been disclosed. No injuries or deaths have been reported at this time.

What to Do

Patients and healthcare providers should stop using the device immediately. Contact Baxter Healthcare or your healthcare provider for guidance on the recall.

Contact Information

For further information, call Baxter Healthcare Corporation at 1-800-XXX-XXXX or visit their website.

Key Facts

  • Recall date: August 8, 2025
  • Quantity recalled: 14,400 units
  • Classification: Class II
  • Contact Baxter for more instructions
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI/DI 00085412048994
Lot Number R24I20079
Exp. 9/21/2026
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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