Inspections, Compliance, Enforcement, and Criminal Investigations
Vital Signs, Inc. 12/1/08
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
DEC 1 2008
Via Federal Express
Terry D. Wall
CEO and President
Vital Signs, Inc.
20 Campus Road
Totowa, New Jersey 07512
Dear Mr. Wall:
On September 25,2008, the Food and Drug Administration (FDA) obtained information from your Internet website, http://www2.vitalsignscom/vsihome/html/english/products/critical/enFlowFluidWarming.aspx that revealed serious regulatory problems involving the enFlow® IV Fluid/Blood Warming System. This product is offered for sale and commercially distributed by your firm.
Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C.
321 (h), this product is a device because it is intended for use in the diagnosis of disease
or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are
intended to affect the structure or function of the body. The Act requires that
manufacturers of devices that are not exempt obtain marketing approval or clearance for
their products from the FDA before they may offer them for sale. This helps protect the
public health by ensuring that new devices are shown to be both safe and effective or
substantially equivalent to other devices already legally marketed in this country for
which approval is not required.
Specifically, your website makes the claim in the on-line operator's manual that the
"enFlow® IV Fluid/Blood Wanning System" will reduce surgical infections. We note
that this device differs from your "eFlow™ IV Fluid Warmer" device in both name and
intended use. The 510(k) Submission, K060537, for your eFlow™ IV Fluid Warmer
states such device is intended for warming blood, blood products, and intravenous
solutions prior to administration and is intended to be used by healthcare professionals in
hospital, clinical and field environments to help prevent hypothermia. The 510(k) for the
eFlow™ IV Fluid Warmer was not cleared for use to reduce surgical infections.
A review of our records reveals that you have not obtained marketing approval or clearance
before you began offering your product for sale, which is a violation of the law.
Specifically, our review of your website revealed that the enFlow® IV Fluid/Blood
Warming System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C.
351 (f)(1)(B), because you do not have an approved application for premarket approval
(PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved
application for an investigational device exemption (IDE) under section 520(g) of the
Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(0) the Act, 21
U.S.C. 352(0), because you did not notify the agency of your intent to introduce the
device into commercial distribution, as required by section 51O(k) of the Act, 21 U.S.C.
360(k). For a device requiring premarket approval, the notification required by section
510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before
the agency. 21 CFR 807.81(b). The kind of information you need to submit in order to
obtain approval or clearance for your device is described on the Internet at
http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information
you submit and decide whether your product may be legally marketed.
A review of our records also revealed that the enFlow® IV Fluid/Blood Warming System
is misbranded under section 502(0), 21 U.S.C. 352(0), in that the device was not included
in a list required by section 51 O(j), 21 U.S.C. 360(j). Specifically, you did not list the
enFlow® IV Fluid/Blood Warming System with the FDA (see 21 CFR 807.20).
You should take prompt action to correct the violations addressed in this letter. Failure to
promptly correct these violations may result in regulatory action being initiated by the
Food and Drug Administration without further notice. These actions include, but are not
limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are
advised of the issuance of all Warning Letters about devices so that they may take this
information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you
receive this letter of the specific steps you have taken to correct the noted violations,
including an explanation of how you plan to prevent these violations, or similar
violations, from occurring again. Include documentation of the corrective action you
have taken. If your planned corrections will occur over time, please include a timetable
for implementation of those corrections. If corrective action cannot be completed within
15 working days, state the reason for the delay and the time within which the corrections
will be completed.
Your response should be sent to: Betty W. Collins, Director, Division of Enforcement A,
HFZ-320, 9200 Corporate Blvd, Rockville, MD, 20850. If you have any questions about
the content of this letter please contact: Betty W. Collins at 240-276-0115 or FAX 204276-
It is your responsibility to ensure compliance with applicable laws and regulations
administered by FDA. You should investigate and determine the causes of the violations,
and take prompt actions to correct the violations and to bring 'your products into
Timothy A. Ulatowski
Office of Compliance
Center for Devices and