Posts Tagged 'Recall'

Zimmer Biomet Recalls Shoulder Device Due to High Fracture Rates

zimmer recalls shoulder implantMedical device manufacturer Zimmer Biomet has recalled its Comprehensive Reverse Shoulder implant. The device was intended for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and had a previously failed shoulder joint replacement.

The Comprehensive Reverse Shoulder is being recalled because the devices are fracturing at a higher rate than is stated in the product’s labeling. Device fractures may result in the need for revision surgeries ...

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Medtronic Heart Pump Recalled Over Potentially Fatal Flaw

medtronic heartware hvad system under recallLast year, medical devices manufacturer Medtronic bought HeartWare, the company behind a heart pump known as the HVAD system. The deal cost Medtronic $1 billion.

Prior to the purchase, HeartWare had received not one, but two safety letters from the U.S. Food and Drug Administration over issues related to the HVAD pump. These letters detailed agency concerns over the effects of moisture on the HVAD system. Medtronic was aware of ...

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Hospira Recalls Defective Infusion Pumps

hospira to recall infusion pumpsThe pharmaceutical company and medical device manufacturer Hospira, Inc., has issued a Class I recall of its Plum A+ and A+3 infusion pumps, according to the FDA website. The pumps have an alarm that is supposed to trigger when therapy is interrupted. However, some of the pumps’ alarms fail to sound in situations that should trigger them.

Class I recalls are the most serious class of recalls, and are issued when recalled ...

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Recall for Sigma Spectrum Infusion Pumps

The FDA recently announced an immediate product recall of Sigma Spectrum Infusion Pumps. The recall affects pumps with model numbers 35700BAX and 35700ABB that were manufactured between July 1, 2005 and January 15, 2014.

The Spectrum Infusion Pump is a medical product widely used by hospitals and home health care professionals. It is used to administer intravenous fluids into a patient’s vein, artery, or spine, or under the skin. Intravenous fluids can include blood, saline, or medicine.

The Sigma Spectrum ...

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GM Recalls Additional Vehicles On the Heels of Safety Issues

After recently recalling 1.6 million Chevrolet Cobalts and Saturn Ions due to a faulty ignition switch that has been linked to numerous accidents, GM stopped sales of 2013 and 2014 Cruzes. The order to stop sales of the vehicle was done without any explanation at the time, but typically signifies a decision to fix a safety issue before a car is sold, thus avoiding a later recall to fix the problem.

Chevrolet Cruzes ...

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Nationwide recall of all sterile drugs from compounding pharmacy

An FDA News Release reports of a nationwide voluntary recall of all non-expired sterile drugs distributed by Abrams Royal Compounding Pharmacy. The Dallas company is recalling all intravenous injections, injectable medication, eye drops, nasal sprays, pellet implants, inhalation solutions, and eye ointments made between June 17th and December 17th 2013.

The FDA is alerting all health care professionals to stop using affected products as they may cause serious ...

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