Note. This article was updated on September 16, 2020, with additional details from the U.S. Food and Drug Administration describing the four situations, the manufacturing and distribution dates for the affected models, and the total number of affected devices for the recall.

On September 1, 2020, the U.S. Food and Drug Administration (FDA) designated three of the situations involved in BD’s June 30, 2020, previously announced voluntary recall of several models of its Alaris™ system as class I recalls. Class I recall designation indicates a reasonable probability that the use of the product will cause serious adverse health consequences or death.

FDA Designates Majority of BD’s June 30 Alaris Pump Recall as Class I

A fourth situation 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. The FDA designations do not change the guidance BD provided in its June recall announcement to customers.

BD initiated the voluntary recall to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected and provided instructions to correct or mitigate the situations:

  • Situation 1: Damaged inter-unit (IUI) interface connectors (class I): Damaged IUI connectors may lead to interruption of communication or power between PC unit and modules, which could result in an infusion that stops with an alarm on the PC unit and an interruption of therapy or monitoring.
  • Situation 2: Broken elements on Alaris pump module platen (class I): A broken upper hinge post, lower hinge, or membrane frame on the pump module may prevent the device from delivering an accurate amount of fluid, which may result in an overinfusion, free-flow conditions, or underinfusion without an alarm.
  • Situation 3: Improperly secured PC unit battery (class I): If the battery is not properly secured to the unit that is running on battery power, the system may experience a power loss with a prolonged, nonsilenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.
  • Situation 4: Dim LED segments (class II): The LED display on the module may have some segments that appear dim, and therefore, the number may not be clearly displayed. The purpose of this display is to provide the clinicians with infusion or patient monitoring values associated with the type of module. If this dim segment is discovered during clinical use, it may cause slight user confusion or inconvenience.

The affected units were manufactured and distributed from July 1, 2004–April 30, 2020. BD reported that 2,451,858 devices are involved in the recall.

Customers should review and follow the instructions in the recall letter.

Affected Products

Model

Situation 1

Situation 2

Situation 3*

Situation 4

Alaris System PC Unit Model 8000

X

 

X

 

Alaris System PC Unit Model 8015

X

 

X

X

Alaris Pump Module Model 8100

X

X

 

X

Alaris Syringe Module Model 8110

X

   

X

Alaris PCA Module Model 8120

X

   

X

Alaris EtCO2 Module Model 8300

X

   

X

Alaris SpO2 Module Model 8210 and Model 8220

X

   

X

Alaris Auto ID Module Model 8600

X

 

 

 

*Because situation 3 affects the PC unit batteries, it may cause power loss to any attached module.

Some affected devices may be branded under the CareFusion name. Customer inquiries related to the action should be addressed to BD’s Recall Support Center at 888-562-6018 or SupportCenter@bd.com.