Jim Vititoe | May 5, 2010
FDA notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those [...]
Jim Vititoe | March 24, 2010
FOR IMMEDIATE RELEASE - March 12, 2010 - Limerick, PA - Teleflex Incorporated provided an update today on the previously announced Arrow International, Inc. voluntary recall of ALL lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010.
Testing revealed [...]
Jim Vititoe | March 24, 2010
FDA NEWS RELEASE
For Immediate Release: March 22, 2010
Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
FDA Recommends Clinicians Temporarily Suspend Use of Vaccine as Agency Learns More
FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United [...]
Jim Vititoe | March 17, 2010
FDA NEWS RELEASE
For Immediate Release: March 16, 2010
The U.S. Food and Drug Administration today ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, [...]
Jim Vititoe | March 17, 2010
FDA NEWS RELEASE
For Immediate Release: March 11, 2010
Counterfeit polypropylene mesh products marketed as C. R. Bard/Davol
The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where [...]
Jim Vititoe | February 3, 2010
FDA notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System, Model number GEF09800, because of reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected, the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. It is possible to [...]
Jim Vititoe | February 3, 2010
FDA notified healthcare professionals of a Class I recall of Hettich Centrifuges with 2050 and 2076 plastic rotors, used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. The recall was initiated because the plastic centrifuge rotor may crack, break apart and be forcefully ejected through [...]
Jim Vititoe | February 3, 2010
Exel/Exelint Huber needles,
Exel/Exelint Huber Infusion Sets
Exel/Exelint “Securetouch+” Safety Huber Infusion Sets
Audience: Hospital Risk Managers, Surgical Service personnel
[Posted 01/26/2010] FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation. Huber needles are [...]
Jim Vititoe | February 3, 2010
FDA NEWS RELEASE
For Immediate Release: Jan. 26, 2010
Media Inquiries: Peper Long, 301-796-4671, mailto:mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.
Huber needles are used to access [...]
Jim Vititoe | January 25, 2010
Contact:
Darrall Pride
978-232-3957 x 110
FOR IMMEDIATE RELEASE - January 21, 2010 - Hettich Centrifuges, Beverly, MA, is initiating a North America and Canada recall of 2050 and 2076 plastic hematocrit rotors that are used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. These plastic rotors have the [...]