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Infusion pump recall updates

by Barbara Kram, Editor | July 20, 2010
Infusion pump update
Hospira Update:

On July 15, 2010 FDA posted a Class I recall of the Symbiq One-Channel Infuser (Model 16026) and Symbiq Two-Channel Infuser (Model 16027), manufactured by Hospira because there is potential for the devices to fail to detect air in the line at the end of an infusion.

Class I 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 adverse health consequences or death.

Hospira mailed clinical bulletins to affected customers on April 9, 2010, and an updated clinical bulletin on June 11, 2010 (see link at the end of this paragraph). In the June 11, 2010 letter, Hospira states that users do not have to remove or stop using the Symbiq infusion pump and the company provides detailed instructions on how to use the pumps for those who choose not to replace them. Read the details at:
http://www.hospira.com/ClinicalResources/ClinicalBulletins.aspx

Read the FDA recall update:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.htm




Baxter Update:

Baxter International Inc. has announced final details regarding its previously communicated COLLEAGUE Infusion Pump Recall in the U.S., to be executed over 24 months.

Baxter announced July 13 that the FDA has issued its final order regarding the previously communicated recall of COLLEAGUE infusion pumps from the U.S. market. Baxter will offer replacement infusion pumps or refunds to owners of COLLEAGUE pumps and will execute the recall over the next two years to minimize disruption to patient care.

The replacement option permits customers to exchange COLLEAGUE infusion pumps for Sigma SPECTRUM next-generation smart pumps. Alternatively, COLLEAGUE pump owners may receive the lesser of the pump's depreciated value, which will be no less than $1,500 per single-channel pump and $3,000 per triple-channel pump, or the purchase price. Customers who did not purchase their pumps directly from Baxter must provide proof of purchase to verify the purchase price in order to qualify for a refund. Baxter will also permit U.S. pump lessees to terminate their leases without penalty upon the return of the devices.

Get more details:
http://www.baxter.com/press_room/press_releases/2010/07_13_10_colleague.html

Because of ongoing problems with infusion pumps, FDA has an initiative to improve the technology and minimize risks by establishing additional requirements for infusion pump manufacturers; proactively facilitating device improvements; and increasing user awareness.