Printer Friendly

INFUSAID PAYS $290,000 FINE FOR MARKETING UNAPPROVED MEDICAL DEVICE

 WASHINGTON, Nov. 23 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced that the manufacturer of an inplantable infusion pump, used to give patients drugs, has agreed to pay a $290,000 fine for marketing an unapproved medical device.
 The civil money penalty against Infusaid Inc. of Norwood, Mass., a division of Pfizer Hospital Products Group, is the first imposed by FDA under the Safe Medical Devices Act of 1990.
 Infusaid was cited for distributing a drug pump to which it had made significant changes, without FDA approval. Infusaid's altered pump -- a model 400 -- leaked, potentially endangering health by delivering too much drug to some patients. The firm received 10 complaints of product failure or patient injury.
 In addition, the firm was cited for failing to manufacture the device in accordance with Good Manufacturing Practice regulations because the pumps failed to meet the firm's specifications. Both problems were uncovered during FDA inspections of the firm.
 Infusaid agreed to pay the fine without admitting liability, wrongdoing or illegal conduct.
 "FDA regulations are intended to protect the public health, and we expect companies to take them seriously," said FDA Commissioner David A. Kessler, M.D. "Medical devices can save lives, but they can also injure patients if they are not properly manufactured."
 Although Infusaid had FDA approval for its original pump, it is required by law to get approval for changes that could affect safety and effectiveness. In this case, changes were made in the design, the material used and the packaging without FDA approval.
 Between November 1990 and November 1991, Infusaid made 1,591 shipments of the unapproved pump. In December 1991, after numerous complaints, the firm recalled all the pumps. Those now on the market have been re-designed and approved by FDA.
 FDA is one of eight Public Health Service agencies within HHS.
 -0- 11/23/93
 /NOTE TO EDITORS: Attention TV Broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Sharon Snider of the Food and Drug Administration, 301-443-3285 or, home, 301-622-0977/


CO: U.S. Food and Drug Administration; Infusaid Inc. ST: District of Columbia IN: HEA MTC SU: EXE

IH-DC -- DC030 -- 7357 11/23/93 15:12 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Nov 23, 1993
Words:363
Previous Article:CP&L'S PROJECT SHARE WARMS NEEDY HOUSEHOLDS
Next Article:PROACTIVE CORP. REDUCES EMPLOYMENT PRACTICES LIABILITY RISK
Topics:

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters