The FDA has identified the recall of the Alaris Infusion Pump Module 8100 Bezel as a Class I recall, the most serious type. Use of these devices may cause serious injuries or death.
This recall applies to the Alaris Infusion Pump Module Model 8100 Front Bezel purchased and/or installed by Pacific Medical Group (DBA Avante Health Solutions) with distribution dates between July 10, 2020 and February 18, 2021.
The Alaris Infusion Pump Module Model 8100 is used to deliver fluids such as medications, nutrients, blood, and other therapies into a person’s body, in controlled amounts. The front bezel component is critical to the proper performance of the infusion pump. Bezel posts from Pacific Medical Group are used to service and repair infusion pump modules.
Reason for Recall
Pacific Medical Group (DBA Avante Health Solutions) is recalling the affected products and devices because the front bezel components may crack or separate, leading to inaccurate delivery of fluids to patients. The separation of one or more bezel posts may result in:
- free flow of fluids to patient
- over delivery or under delivery of fluids delivered to a patient
- interruption of fluids delivered to a patient
There have been 62 complaints reported about this device issue and one death may have been related to this recall. No other injuries have been reported.
This recall is related to Tenacore’s recent recall of the Alaris pump bezel assembly and Alaris infusion pumps repaired with the bezel assembly.
What to Do
On March 24, 2021, Pacific Medical Group (DBA Avante Health Solutions) sent a Medical Device Recall Notification to all affected customers. The letter requested that customers take the following actions:
- Identify if you have affected product.
- Remove affected devices from clinical use and immediately quarantine them until the impacted parts can be returned to Pacific Medical Group.
- Contact Customer Service at 800-449-5328 or by email at [email protected] to start the process for replacement.
- Once returned to customer service, the affected device will be evaluated, inspected, and replaced by Avante Health Solutions and then returned to the customer.
- If you have resold or distributed the affected product, please forward this notice to your customers.
- Complete and return the customer acknowledgement form.
Customers who have questions about this recall should contact Avante Health Solutions customer service at 800-449-5328 or by emailing [email protected].