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U.S. Department of Health and Human Services

Medical Devices

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Cardinal Health Alaris® Infusion Pump Module (formerly Medley™ Pump Module), Model 8100

Class 1 Recall
Date Recall
Initiated
 October 29, 2007
Product:

Cardinal Health Alaris® Infusion Pump module (formerly MedleyTM Pump module), Model 8100

All Alaris® Infusion Pump modules shipped prior to September 27, 2007 are subject to this recall.

See this list of serial numbers for Alaris® Infusion Pumps affected by this recall. 
Use:

Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.

 
Recalling Firm:

Cardinal Health 303 Inc DBA Alaris Products
10221 Wateridge Cir
San Diego, California 92121-2733

 
Reason for Recall:

During the manufacturing or servicing of the mechanism assembly, the occluder springs were misassembled (overlapping [nested], missing, bent or broken). If a spring is misassembled, there is a potential for inaccurate flow rate which may lead to a patient’s harm due to over-infusion.

 
Public Contact:
 Customers may call the company’s Call Center at 1-800-625-6627.
FDA District:
 Los Angeles
FDA Comments:

On November 5, 2007, the company sent out a recall notice to their customers.  This recall notice contained "Service Bulletin 528," which described an interim test to verify that the device is operating correctly. Specifically, this test determines the presence of the device’s occluder springs, which are used by the device to control the flow of medication.

On December 20, 2007, the company issued a press release about this recall. The company had revised the original service bulletin because customers complained that the test could not consistently verify the presence of the occluder springs within a device. The company issued a new “service bulletin 528A” to their customers.

For more information about this recall, please see the company’s press release. 

See a copy of the revised Service Bulletin 528A.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.  See the nearby link to MedWatch. 

 

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