Navigation Links
Medical Device Recalls Soar During First Quarter, ExpertRECALL Index Shows
Date:5/14/2012

INDIANAPOLIS, May 14, 2012 /PRNewswire/ -- Medical device recalls increased more than 160 percent in the first quarter of 2012, affecting more than five times as many units than the previous quarter, according to the quarterly ExpertRECALL™ Index, released today.

Products impacted by the increase include alcohol prep pads, catheters, needles and latex gloves. Consumer product recalls also increased in the first quarter of 2012. Conversely, the ExpertRECALL Index found that pharmaceutical and food recalls decreased compared with previous quarters.

Medical device recalls documented in first quarter U.S. Food and Drug Administration (FDA) Enforcement Reports affected nearly 82 million units, representing a 508 percent increase over the previous quarter and recording a five-quarter high. Additionally, about one-third of companies that faced recalls in the first quarter were involved in more than one recall event -- a trend that has continued over the last five recent quarters.

"While the quarter-over-quarter increase in medical device recalls is significant, this change was not all that unexpected given that recalls documented in fourth quarter 2011 Enforcement Reports were at an unprecedented low," explained Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL. "However, what is troublesome is the dramatic increase in units affected by the recalls and continued number of repeat offenders. It's scary to think about given the increasing number of devices that American patients rely on to maintain and improve their health. Consumer and patient safety should be the number-one priority for every manufacturer, distributor, retailer, doctor's office and healthcare facility."

"Companies should be doing everything possible to minimize the safety concerns that would result in recalls," Rozembajgier said. "Similarly, any business or individual within a supply chain, whether a distributor or a doctor, should keep close tabs on the products they handle to ensure that potential safety concerns are identified early and reported to the manufacturer and the regulatory agency. This due diligence ensures that the impact of recalls, when they do happen, is minimized. Ultimately fewer units, and thus fewer consumers, will be affected."

The ExpertRECALL Index also found that while pharmaceutical recalls hit a five-quarter low, the recalls documented in FDA Enforcement Reports affected more units than in the previous four quarters. Of the recalls documented, 20 percent affected over-the-counter drugs while 80 percent affected prescription medications.

Consumer product recalls initiated at the request of the Consumer Product Safety Commission (CPSC) increased 24 percent quarter-over-quarter with fire hazards as the leading cause of recalls. While the consumer product category overall logged more recalls compared with the previous quarter, recalls of children's products reached a five-quarter low and accounted for just 13 percent of CPSC recalls.

Food recalls documented in first quarter FDA Enforcement Reports decreased 19 percent. Of first quarter recalls, 56 percent earned the FDA's most severe "Class I" designation.

The 2012 first-quarter ExpertRECALL Index is the only report that aggregates and tracks cumulative recall data from the CPSC and the FDA. Stericycle ExpertRECALL compiles the ExpertRECALL Index from data issued by the U.S. Food and Drug Administration and the Consumer Product Safety Commission. The ExpertRECALL Index report is available online at http://www.expertrecall.com/recallindex.

About Stericycle ExpertRECALL™
Stericycle ExpertRECALL™ is the industry leader in managing consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. Stericycle ExpertRECALL streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for a variety of companies. For more information, visit http://www.expertrecall.com.


'/>"/>
SOURCE Stericycle ExpertRECALL
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. ICU Medical, Inc. Plans to "Vigorously Seek to Collect Damages" in wake of Patent Infringement Victory Over RyMed Technologies
2. Flexpoint Receives Purchase Order for Medical Device Used in Procedure Performed Millions of Times Annually
3. Exclusive Industry Panel for Medical Device Developers - "The Great Innovators: A Sit-Down Chat with Dr. Thomas Fogarty & Dean Kamen"
4. Millstone Medical Outsourcing Hires New Vice President Quality
5. WAISMANN METHOD® Medical Director Voices Support for Fibromyalgia Awareness Day
6. Dehaier Medical Announces 2012 First Quarter Financial Results
7. Coloplast Wins Patent Infringement Verdict Against Generic Medical Devices, Inc.
8. Brainybrawn, Inc. announces Launch of its Web based Medical College Information Management Solution (Sanvi MCIMS), as well as Receipt of Order for Its Comprehensive Restaurant Information Management Solution for Managing Chain of Restaurants (Sanvi
9. Childrens National Medical Center Breaks MRI Speed Sound Barrier
10. Aethlon Medical Reports Undetectable Hepatitis C Virus (HCV) in Genotype 1, Genotype 3, and Genotype 5 Patients Treated with Hemopurifier® Therapy
11. Medical Reprints Deployment on iPads and Websites Made Easier with New ePrints Mobile-Web App from Reprints Desk
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/25/2017)... , Sept. 25, 2017   Montrium , ... File solutions, today—from the IQPC Trial Master Files ... , NL)—announced that EastHORN Clinical Services has selected ... programs and TMF management. EastHORN, a leading European ... platform to increase transparency to enable greater collaboration ...
(Date:9/22/2017)... 2017  As the latest Obamacare repeal effort moves ... (R-LA) and Lindsey Graham (R-SC) medical ... device industry is in an odd place.  The industry ... excise tax on medical device sales passed along with ... patients, increased visits and hospital customers with the funding ...
(Date:9/19/2017)... 19, 2017   ZirMed Inc ., a recognized leader ... that it has been ranked #1 by its users for ... Rankings 2017 User Survey. ZirMed was recognized as the top-ranked ... and medical centers over 200 beds and holds one of ... user survey history. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at ... towards children of all ages; it is a non-competitive, non-timed event, which is all ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history ... The Brink” is the creation of published author, William Nowers. Captain Nowers and ... WWII veteran, he spent thirty years in the Navy. Following his career as ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one ... an innovative new design of the shoulder pad. The shoulder pad provides optimal ... controlling your pain while using cold therapy. By utilizing ice and water that is ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader ... a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were ... 11, 2017. , The annual award competition recognizes editorial and design excellence across a ...
(Date:10/12/2017)... ... October 12, 2017 , ... In ... taxes a year. In some states—like New York, New Jersey, Massachusetts, Texas, Virginia, ... overseas retirement havens have extremely low property-tax rates, which contributes to the relatively ...
Breaking Medicine News(10 mins):