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 Infusion Pump Repair
- Models: Alaris Model 8100
- Product Number: TIPA-8100-4410
- Lot Number: 20200608
- Devices Recalled in the U.S.: 15
- Distribution Date: January 15, 2021 to March 14, 2021
- Date Initiated by Firm: March 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 Infusion Pump Repair are used to service and repair infusion pump modules.
Reason for Recall
Infusion Pump Repair 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 Infusion Pump Repair.
- Patients who require care using the Alaris Pump Module Model 8100 with an affected bezel serviced by Infusion Pump Repair.
What to Do
On March 24, 2021, Infusion Pump Repair 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.
- Immediately quarantine the potentially affected devices.
- Inspect the potentially affected devices to determine if the impacted bezel repair part is installed.
- Contact Infusion Pump Repair 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
The letter also requested device dealers and distributors:
- Share the recall notification letter with customers who may have received the potentially impacted pumps.
Customers can contact the recalling firm at: 855-477-8866 or firstname.lastname@example.org.
- Medical Device Recall Database Entry
- 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.