Power Pac Batteries Recalled By Covidien Over Patient Safety Risk
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 Recalled Over Display Error
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
ShapeMatch Cutting Guide Recall Designated Class I By FDA
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
Smiths Medical Recalls BCI Remote Alarm Cables Over Patient Risk
A series of medical devices that are designed to alert caregivers to a potential problem are being recalled because there’s a possibility that the alarm sounds would not be emitted properly. Smiths Medical announced the recall, which affects BCI Remote Alarm Cables used in conjunction with the 9004 Canocheck Capnography System. The device is used… read more
Chicago DePuy ASR Trial Testimony Offers Revealing Information
It’s been a few weeks since a Los Angeles jury awarded a plaintiff $8.3 million for the ordeal he was put through after being implanted with the DePuy ASR metal on metal hip implant, a device which later failed. Thousands of people have filed similar lawsuits, and one of those is currently underway in Chicago…. read more
Air Embolism Risk Leads to Recall of Guardian II Hemostasis Valves
The potential threat of an air embolism has prompted Vascular Solutions to announce the recall of Guardian II NC and Guardian II Hemostasis Valves available between February of last year and this past February. The recall encompasses four separate model numbers: 8215, 8216, 8210, and 8211. These particular models could suffer from a defect that… read more
Infant Warmer Component Recalled By GE Over Possible Health Risk
A component that could be found within Panda and Giraffe infant warmers is being recalled by GE Healthcare. The recall pertains to the field upgrade kit for resuscitation systems with blender. Each of the affected upgrade kits would have been produced between April 2008 and September of last year. Owners began receiving notices as early… read more
Reusable Breathing Circuit Recalled by Fisher & Paykel Over Leak Risk
Reusable Breathing Circuits from Fisher & Paykel Healthcare are being recalled because a certain defect could lead to the patient’s fatality. Model 900MR068 is affected by the recall, which was initiated upon discovery that the tubes may have been compromised by pinholes. If a test does not reveal the presence of these pinholes, a gas… read more
Glidescope GVL Video Laryngoscopes Recalled Over Injury Risk
Glidescope GVL Video Laryngoscope reusable blades are being recalled by the Bothell, Washington-based Verathon Inc. because there’s a possibility that the tips of the blades could crack or even break. If this occurs while a doctor is tending to a patient, it could lead to the blade cracking away inside the mouth of the individual. … read more
Isovue Syringes Recalled by Bracco Diagnostics for Particle Risk
Isovue Pre-Filled Power Injector Syringes are being recalled by Bracco Diagnostics because particulate matter was identified in certain samples. Nine lots are affected by the recall. These items are supposed to be used for cardiovascular diagnostic purposes in the form of an angiography by a doctor, and the substance gets injected directly into the arteries. … read more
A3/A5 Anesthesia Delivery Systems Recalled by Mindray Medical
A3/A5 Anesthesia Delivery Systems that were distributed from May 31 of last year to this past July 15 have been recalled by Mindray Medical International Limited. If the CO2 absorber canister gasket is not seated accurately on the device, then a leak could potentially occur. A customer detailed an apparent leak to the company in… read more
Several Neptune Waste Management Systems Recalled For Injury Risk
Stryker has recalled its Neptune Waste Management Systems used for medical drainage. One fatality and an additional serious injury have resulted from use of the high vacuum/high flow devices. Several models did not receive 510(k) clearance from the FDA prior to sale and are not considered legally marketed medical devices. Those who have no other… read more