HIGH

Baxter Healthcare Recalls IV Sets Due to Leakage Risk

Baxter Healthcare recalled 18,720 IV solution sets on August 29, 2025, due to a leak hazard. The recall affects devices distributed across the United States, including all 50 states. Patients and healthcare providers should stop using these devices immediately.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
Baxter Healthcare
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

IV sets may leak.

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

Product Details

The recalled product is the CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2.4 m), Product Code: 2H8519. These IV sets were distributed nationwide and are identified by the model UID/DI 00085412625553 and lot number R25C08147.

The Hazard

The IV sets may leak, posing a risk to patients receiving intravenous treatment. Leakage can lead to medication errors or inadequate drug delivery, increasing the risk of adverse health outcomes.

Reported Incidents

As of the report date, there are no reported injuries or deaths associated with the leakage of these IV sets. The recall is classified as Class II, indicating a potential risk of serious injury.

What to Do

Stop using the recalled IV sets immediately. Follow the recall instructions provided by Baxter Healthcare or contact your healthcare provider for further guidance.

Contact Information

For more information, contact Baxter Healthcare Corporation. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0204-2026 for detailed instructions.

Key Facts

  • Recalled product: CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET
  • Quantity: 18,720 units recalled
  • Recall date: August 29, 2025
  • No injuries reported
  • Stop using the product immediately
View Original Recall on FDA - Medical Devices

Get Alerts for Health & Personal Care Recalls

Get notified about recalls in categories you care about.

Safety Assessment

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

Product Classification

Product TypeIV Solution Set
Sold At
Multiple Retailers

Product Details

Model Numbers
UID/DI 00085412625553
Lot numbers: R25C08147
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more