Cardinal Health, Various Modules of the Alaris System
|Recall Class:||Class I|
|Date Recall Initiated:||June 12, 2009|
Alaris Point-of-Care (PC) Unit (Model 8000 and 8015) (formerly Medley PC unit)
Alaris Pump Module (Model 8100) (formerly Medley Pump Module) – Direct for Use (DFU) update
Alaris System (Formerly Medley System) – DFU Update
|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 dba Cardinal Health|
10020 Pacific Mesa Boulevard
San Diego, California 92121-4386
In July 2009, Cardinal Health 303 dba Cardinal Health announced that they will change their name to CareFusion. The firm expects the official name change to occur on September 1, 2009.
|Reason for Recall:|
The following are potential risks of the system:
Customers may contact the firm at the following numbers:
|FDA District:||Los Angeles|
On June 12, 2009, the company sent letters to each of their customers informing them of the problems. Customers were asked to promptly complete and return the enclosed Customer Response Card to speed up the correction process. The letters also contained very detailed instructions to correct each of the above problems.
On July 29, 2009, the company sent an updated letter to each of their customers. The update contained an additional required action that users must take when the Syringe Volume Warning Message appears on the Alaris System. The additional step involves removing the patient-controlled Dose Request Handset from the patient prior to reprogramming the infusion pump.
For more information about this recall, please see under Useful Links below.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.