HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
HIGH
Baxter Healthcare Recalls IV Solution Set Due to Leak Risk
Baxter Healthcare recalled 49,200 IV solution sets on August 29, 2025. The recall affects products that may leak, posing a risk to patients. Healthcare providers and patients 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 CONTINU-FLO Solution Set, Non-Vented, featuring two CLEARLINK Luer Activated Valves and a Backcheck Valve. The affected model codes include UDI/DI 00085412046310 and lot numbers R25C26161 and R25D01031.
The Hazard
The IV solution sets may leak, which can pose serious health risks to patients receiving intravenous therapy. This recall falls under Class II, indicating a potential for temporary or medically reversible adverse health consequences.
Reported Incidents
As of the recall date, no specific incidents or injuries have been reported. The potential for leaks raises concerns for patient safety.
What to Do
Stop using the recalled IV solution sets immediately. Follow the recall instructions provided by Baxter Healthcare and contact your healthcare provider for further guidance.
Contact Information
For more information, contact Baxter Healthcare Corporation directly. Visit their website or call their customer service for instructions regarding the recall.
Key Facts
- Recall date: August 29, 2025
- Quantity: 49,200 units
- Class II recall
- Affected states: All US states
- Manufacturer: Baxter Healthcare
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
Brand
Categories
Model Numbers
UDI/DI 00085412046310
Lot numbers: R25C26161 and R25D01031
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:
HIGH
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect