The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Alaris Infusion Pump Module Model 8100 Bezel, purchased and/or installed by Step-Har Medical
- Models: Alaris Model 8100
- Serial Numbers: 12747983 and 9919591
- Devices Recalled in the U.S.: 2
- Date Initiated by Firm: February 26, 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 bezel component is critical to the proper performance of the infusion pump. Bezels from Step-Har Medical are used to service and repair infusion pump modules.
Reason for Recall
Step-Har Medical is recalling the affected products and devices because the 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 a patient
- over delivery or under delivery of fluids delivered to a patient
- interruption of fluids delivered to a patient
If this device issue occurs, this could cause serious patient harm.
There have been no deaths, complaints or injuries reported for this recall.
This recall is related to Tenacore’s recent recall of the Alaris pump bezel assembly and Alaris infusion pumps repaired with the bezel assembly.
Who May be Affected
- Health care providers using the Alaris Pump Module Model 8100 with an affected bezel serviced by Step-Har Medical
- Patients who require care using the Alaris Pump Module Model 8100 with an affected bezel serviced by Step-Har Medical
What to Do
On February 26, 2021, Step-Har Medical sent a recall notification letter via email. Similar to the Tenacore recall notification, the letter requested that customers:
- Review the serial number list of pumps that are potentially impacted by the recall.
- Remove potentially affected devices from clinical use and immediately quarantine them
- Contact Step-Har Medical to schedule bezel repair part replacement. The impacted bezel repair part must be replaced before the pump can be returned to service.
- Complete and return the Customer Response Form
Customers who have questions about this recall should call 657-267-0054 or email firstname.lastname@example.org.
- Medical Device Recall Database Entry
- Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
- Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts (parent firm for this recall)
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.