Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE

Consumer Watchdog Blasts FDA Delay on Recall

By Pharmaceutical Processing | March 13, 2009

By MATTHEW PERRONE AP Business Writer WASHINGTON (AP) — A consumer watchdog group scolded the Food and Drug Administration Thursday for taking weeks to evaluate the latest problem with Baxter’s drug pumps, which have been plagued by safety issues for years. In January, Baxter International sent a warning to customers about issues with its Colleague infusion pumps that could cause them to stop pumping and overheat. On Wednesday the company said the FDA classified the announcement as a Class I recall, its most severe warning. The classification applies to problems that can cause “serious adverse health consequences or death.” Public Citizen’s Dr. Sidney Wolfe blasted the agency in a letter Thursday for not moving faster. “Why did it take the FDA 47 days, almost 7 weeks … to decide that this problem was serious enough to merit being classified as a Class I recall?” Wolfe wrote in a letter to acting FDA Commissioner Dr. Frank Torti. FDA’s classification has limited real-world impact. Baxter’s products are not actually being called off the market, but the serious warning is necessary because malfunctions with the devices can be fatal. Wolfe pointed out that Baxter’s infusion pumps have been subject to problems for years. Since 2005 the FDA has issued seven Class I recalls on the Colleague pumps, which have been linked to at least 19 deaths. Wolfe called on the agency to physically remove the devices from hospitals and clinics, where they are used to deliver medicine and intravenous fluids. “Why has the FDA not used its authority for mandatory device recalls, to remove these devices which have a long history of serious, life-threatening problems?” Wolfe asked. The FDA did not respond to requests for comment Thursday evening. A spokeswoman for Deerfield, Ill.-based Baxter noted the company stopped selling the devices in the U.S. in 2005 but said 200,000 are still in use. “If we were to do a full market recall of this device you would create a significant health issue, because it would create a shortage of pumps which are vital to patient care,” said Baxter’s Erin Gardiner. According to Gardiner, the company has upgraded 70 percent of the devices on the market to address previously reported problems. But Wolfe questioned the company’s argument. “If they haven’t sold any of these devices in four years, then someone else must be selling them,” Wolfe said Thursday. “And in all likelihood they haven’t had the same string of problems seen with these products.”

Related Articles Read More >

kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
Disposable syringe and American currency on black background
PBMs increasingly under fire in drug-pricing battle
Johnson & Johnson logo
Timeline: Navigating Johnson & Johnson’s talc lawsuits and their stock performance impact
pharmaceutical industry. Production line machine conveyor with glass bottles ampoules at factory
5 core trends in drug recalls: An analysis of 2022 and Q1 2023
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE