Baxter Announces Final Details Regarding Previously Communicated COLLEAGUE Infusion Pump Recall in the U.S.
July 13 2010 - 1:09PM
Business Wire
Baxter International Inc. announced today that the U.S. Food and
Drug Administration (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.
“Baxter’s goal is to support a seamless transition by providing
choices that best address the needs of our hospital customers and
minimize disruption to the delivery of patient care,” said Peter J.
Arduini, president of Baxter’s Medication Delivery business. “We
are continuing to work with Sigma to increase production capacity
of the SPECTRUM pump in order to meet the anticipated demand for
this device.”
During the 24-month transition period, customers may continue to
use COLLEAGUE infusion pumps and receive service and support
provided that a certificate of medical necessity form has been
completed. Baxter will be providing a transition guide to help
customers in replacing COLLEAGUE infusion pumps. Customers should
continue to visit www.baxter.com for more information regarding
COLLEAGUE activities.
This recall is specific to the U.S. market. Outside the U.S.,
Baxter has continued to update the COLLEAGUE device and will be
initiating an additional program to provide customers with enhanced
COLLEAGUE devices that contain a new battery management system, as
well as further upgrades to software and mechanical systems to
improve the product’s user interface and performance.
“Our actions in the U.S. as well as our planned COLLEAGUE
exchange program outside the United States are intended to
demonstrate our commitment to customers and patients around the
world,” said Arduini.
Financial Information
In the first quarter of 2010, Baxter recorded a charge of $588
million in connection with the COLLEAGUE infusion pump recall and
additional actions the company intends to take outside the U.S. The
reserve included asset impairments and cash costs, including an
estimate of cash refunds or replacement infusion pumps, costs
associated with execution of the recall program and certain
customer accommodations. At this time, the company believes that
the charge is adequate.
About COLLEAGUE Infusion Pumps
Baxter introduced the COLLEAGUE infusion pump in 1997. The
COLLEAGUE pump is a large volume infusion pump used to deliver
medication and fluids intravenously to patients throughout a broad
range of clinical settings, most frequently in hospitals. In 2006,
Baxter entered into a consent decree with FDA under which the
company had been pursuing remediation of the infusion pumps. The
COLLEAGUE pump can continue to be used safely and effectively in
accordance with the operator’s manual and additional instructions
contained in field corrective actions (customer letters).
About Sigma SPECTRUM Pumps
Baxter is the exclusive distributor of the SPECTRUM infusion
pump, a next-generation smart pump manufactured by SIGMA
International, of which Baxter is a minority owner. Weighing
approximately 2.5 pounds and measuring 1/10 the size of many other
large volume pumps, the SPECTRUM pump features technology intended
to help reduce pump-related adverse drug events through the use of
drug libraries that eliminate the need for clinicians to manually
enter commonly used drugs and dosage rates, and features a wireless
connectivity option. SPECTRUM, which is currently available in the
U.S., uses standard, low-cost intravenous administration sets (the
tubing that delivers fluid through the infusion pump to the
patient) such as those manufactured by Baxter.
About Baxter
Baxter Healthcare Corporation is the principal domestic
operating subsidiary of Baxter International Inc. (NYSE: BAX).
Baxter International Inc., through its subsidiaries, develops,
manufactures and markets products that save and sustain the lives
of people with hemophilia, immune disorders, infectious diseases,
kidney disease, trauma, and other chronic and acute medical
conditions. As a global, diversified healthcare company, Baxter
applies a unique combination of expertise in medical devices,
pharmaceuticals and biotechnology to create products that advance
patient care worldwide.
This release includes forward-looking statements concerning the
company's recall of its COLLEAGUE infusion pumps from the U.S.
market, including expectations with respect to the implementation
of the recall, the adequacy of the related charge and customer
accommodations outside of the U.S. The statements are based on
assumptions about many important factors, including the following,
which could cause actual results to differ materially from those in
the forward-looking statements: customer preferences with respect
to electing to receive replacement Sigma SPECTRUM infusion pumps or
cash refunds; Sigma’s ability to build production capacity to meet
customer demand; future actions of the FDA with respect to the
company's implementation of the recall pursuant to the consent
decree, including any sanctions available under the consent decree;
future actions of the FDA or any other regulatory body or
government authority that could delay, limit or suspend product
development, manufacturing or sale or result in seizures,
injunctions, monetary sanctions or criminal or civil liabilities;
product quality or patient safety issues; the financial impact of
the recall; and other risks identified in the company's most recent
filing on Form 10-K and other SEC filings, all of which are
available on the company's website. The company does not undertake
to update its forward-looking statements.
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