What's the Problem?
According to the U.S. Food & Drug Administration (FDA) [1], this recall affects:
- Alaris™ System PC Unit Model 8000
- Alaris™ System PC Unit Model 8015
- Alaris™ Pump Module Model 8100
- Alaris™ Syringe Module Model 8110
- Alaris™ PCA Module Model 8120
- Alaris™ EtCO2 Module Model 8300
- Alaris™ SpO2 Module Model 8210 and Model 8220
- Alaris™ Auto ID Module Model 8600
These infusion pumps may be equipped with the following potentially defective hardware systems:
- Damaged Inter-Unit Interface (IUI) Connectors
- Broken elements on Alaris™ Pump Module platen
- Improperly secured PC unit Battery
- Dim LED Segment(s) on the Alaris™ modules
Three of these situations have been designated as Class I recalls, which means "there is a reasonable probability that the use of the product will cause serious adverse health consequences or death," the FDA said. "One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
This recall began on August 20, 2020.
Are Alaris Infusion Pumps Approved by the FDA?
The FDA granted 510(k) clearance to the updated Alaris infusion pump on July 21, 2023, allowing Becton, Dickinson, and Company (BD) to resume distribution of the infusion pump while remediating or replacing older Alaris devices that have been recalled.
3 years after BD issued a nationwide recall for Alaris infusion pumps, it is hoped that the FDA clearance for the company's updated Alaris system will allow for a “return to full commercial operations,” said Tom Polen, BD’s chairman, president, and CEO.
How Do Alaris Pumps Work?
Alaris infusion pumps come with a point of care unit (PCU) which can be customized with up to 4 modules. These modules are connected to tubes and bags of medicine or other fluids. The modules work together with the PCU to perform various functions.
What is the New Technology of Alaris Infusion Pumps?
A programmed infusion pump, or smart pump, comprises a drug library which is called a dosage error-reduction system. Smart pumps administer IV fluids and drugs while following pre-defined parameters, such as drug concentration and dosage.
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Do I Have an Alaris Infusion Pump Recall Lawsuit?
The Products Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Alaris Infusion Pump Recall Lawsuits. We are handling individual litigation nationwide and are currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured by a recalled infusion pump, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.
