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 8,368 IV Solution Sets on August 29, 2025. The recall stems from potential leaks in the devices, posing a risk to patients. Healthcare providers must stop using the product 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 CONTINU-FLO Solution Set, Product Code 2C8593. It includes a 0.2 Micron Filter, three Luer Activated Valves, and a Backcheck Valve. The set measures 102 inches (2.6 meters) and was distributed nationwide across multiple states.
The Hazard
These IV sets may leak, which poses a significant risk to patients receiving treatment. This recall falls under Class II by the FDA, indicating a moderate risk to health.
Reported Incidents
No specific injury or incident counts were reported. However, the potential for leakage creates a serious hazard during intravenous delivery.
What to Do
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by Baxter Healthcare Corporation.
Contact Information
For further information, contact Baxter Healthcare Corporation directly. Visit the recall webpage at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0196-2026.
Key Facts
- 8,368 units recalled
- Potential for IV set leakage
- Class II recall
- Nationwide distribution in the US
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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 00085412071664
Lot numbers:R25D01161
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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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:
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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