Respironics Issues Worldwide Recall of PLV(R) Continuum(TM) Ventilator
May 05 2006 - 12:51PM
PR Newswire (US)
MURRYSVILLE, Pa., May 5 /PRNewswire-FirstCall/ -- RESPIRONICS, INC.
(Nasdaq/NMS Symbol: RESP) announced today that it has voluntarily
recalled 269 ventilators representing all models and serial numbers
of the PLV(R) Continuum(TM) Ventilator. This recall is being
conducted because the ventilator may suddenly stop providing
mechanical ventilation. This could result in serious injury or
death. The recalled ventilators should not be used until the
problem is corrected. Customers have been directed to quarantine
all PLV Continuum Ventilators and to use other ventilator models.
If a customer does not have a suitable substitute ventilator,
Respironics will loan them a comparable unit. The PLV Continuum
Ventilator is used to provide mechanical ventilation for pediatric
and adult patients who weigh at least 5 kg (11 lbs.). The device is
intended for use at home, in an institution, or as a portable
ventilator. These ventilators have been distributed in the United
States, Australia, Argentina, Canada, Japan, Hong Kong,
Netherlands, Saudi Arabia, and Taiwan. Respironics provided
notification of the recall to distributors, sales personnel, and
customers by letter on March 20, 2006. The firm is continuing to
contact customers to arrange for the return of all the recalled
ventilators. Respironics identified the problem after an analysis
of returned units revealed the potential for failure of an internal
flow valve. The Company has received no reports of adverse events
or injuries resulting from this problem. Respironics notified the
U.S. Food & Drug Administration (FDA) of its decision to
voluntarily recall the product. The recall was classified as a
Class I Recall by the FDA on April 27, 2006. A Class I recall is a
situation in which there is a reasonable probability that the use
of or exposure to a violative product will cause serious adverse
health consequences or death. Customers with questions may contact
the Company at 877-544-9252. Any adverse reactions experienced with
the use of this product, and/or quality problems should also be
reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088,
by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600
Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website
at http://www.fda.gov/medwatch. The Company stated that it will not
be changing its financial outlook or guidance based on this recall.
Respironics is a leading developer, manufacturer and distributor of
innovative products and programs that serve the global sleep and
respiratory markets. Focusing on emerging market needs, the Company
is committed to providing valued solutions to help improve outcomes
for patients, clinicians and health care providers. Respironics
markets its products in 131 countries and employs over 4,600
associates worldwide. Further information can be found on the
Company's Web site: http://www.respironics.com/. This document
contains forward-looking statements, including statements relating
to, among other things, developments in the healthcare industry;
the success of the Company's marketing, sales, and promotion
programs; future sales and acceptance of the Company's products and
programs; the timing and success of new product introductions; new
product development; anticipated cost savings; FDA and other
regulatory requirements and enforcement actions; future results
from acquisitions; acquisition integration; growth rates in foreign
markets; regulations and other factors affecting operations and
sales outside the United States (including potential future effects
of the change in sovereignty of Hong Kong); foreign currency
fluctuations; customer consolidation and concentration; increasing
price competition and other competitive factors in the sale of
products; interest rate fluctuations; expiration of intellectual
property rights; intellectual property and related litigation;
other litigation; future levels of earnings and revenues; and third
party reimbursement, all of which are subject to change. Actual
results may differ materially from those described in any
forward-looking statements. Additional information on potential
factors that could affect the Company's financial results are
included in the reports filed with the SEC, including the reports
on Form 10-K, 10-Q and 8-K. Respironics, Inc. and its affiliates
DATASOURCE: Respironics, Inc. CONTACT: Dan Bevevino, Chief
Financial Officer, Respironics, Inc., +1-724-387-5235; Joe
Calabrese, General Contact, +1-212-827-3772, or Julie Tu, Investor
Contact, +1-212-827-3776, both of Financial Relations Board Web
site: http://www.respironics.com/
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