2013

May has been designated as Asthma and Allergy Awareness Month, and the Food and Drug Administration is using the classification as a platform to inform persons suffering from both asthma or COPD (chronic obstructive pulmonary disease) about an upcoming regulatory deadline that could have an impact on their therapy. By the end of this year,… read more

GOBlock Kits and GoPump Rapid Recovery System kits are being recalled by Symbios Medical Products because of an issue that could compromise patient safety.  Versions of the items that have flow controls put together before July of last year could suffer from flow rates that exceed what would be considered safe.  This could lead to… read more

The Food and Drug Administration has learned that one lot of a certain medical product has been stolen from its place of manufacture and thus its sale to healthcare professionals could leave patients at risk of an infection.  The items stolen were Endo GIA Articulating 60-3.5 Surgical Stapler Reloads from Covidien.  One lot carrying the… read more

Presource Kits with a Filter and Anesthesia Circuit that has already been put together prior to distribution are being recalled by Cardinal Health.  Because this component has been assembled already, persons who remove the outer plastic without first taking apart the component could find pieces of plastic wound up stuck in the filter.  As the… read more

Zilver PTX Drug Eluting Peripheral Stents are being recalled by Cook Medical because of an issue with the catheters that could potentially compromise patient safety.  The products’ delivery system could become dislodged from the inner catheter’s tip, a condition which could cause a host of health complications.  This possible adversity includes cardiac arrest, thrombosis, vascular… read more

LifeScan has announced the recall of OneTouch Verio IQ Meters because of an issue that could compromise safety.  When a person has blood glucose levels above 1024 mg/dL, an amount that would be potentially dangerous to patients, a message explaining that Glucose is extremely high (i.e. higher than 600 mg/dL) is supposed to pop up. … read more

Giraffe Omnibeds and Giraffe Incubators that utilize a Servo Control Oxygen System have been recalled by GE Healthcare because of a possible threat to patient safety.  The recall was actually issued toward the beginning of the year, but GE is issuing this latest announcement as a means to confirm that affected owners have been properly… read more

Prompted by myriad reports of failure that could potentially create circumstances where an infection might spread, the Food and Drug Administration is warning the medical community to take the proper precautions when dealing with medical bed mattress covers. For two years leading up until January, 458 reports came in to the FDA describing a cover… read more

Power Pac batteries have been recalled by Covidien because of an issue that could compromise patient safety when the units are used in conjunction with the HT70 and HT70 Plus Ventilators from Newport.  There are two safety issues of note:  when the ventilators are taken off of AC power, the backup battery source might kick… read more

Freestyle Insulinx Blood Glucose Meters have been recalled by Abbott because there’s a possibility that they wouldn’t display the correct glucose reading in persons who may need prompt medical attention.  The issue takes place when a person’s blood glucose is higher than 1024 mg/dL.  The meter will potentially subtract 1024 mg/dL from the actual glucose… read more

This past January, the Stryker Corporation announced the recall of ShapeMatch Cutting Guides typically used during knee replacement surgery.  The company worried that the products may have been produced in a manner not in line with approved procedural methods or in the parameters laid out in surgical preoperative planning.  At the time, surgeons were told… read more

Many surgeons are turning to robots to conduct certain surgical operations, prompting a spike in the number of such procedures carried out every year.  But a recent uptick in potentially injurious incidents associated with the devices has led to a debate over the safety and efficacy of the technology. At the center of the debate… read more