domingo, 3 de febrero de 2019

Recent Medical Device Recalls


Recent Medical Device Recalls

Draeger Medical Recalls Breathing Circuits and Anesthesia Sets

Draegar Medical is recalling its disposable VentStar and ID Breathing Circuits and Anesthesia Sets due to a risk of the devices being incorrectly assembled, resulting in a short-circuit in the breathing hose. If the breathing hose is short circuited, the patient will not receive the expected breathing support (ventilation). Lack of breathing support may result in irreversible patient harm, up to and including severe oxygen-loss (hypoxia) and death.

West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions

West Pharmaceutical Services Inc. is recalling the Vial2Bag fluid transfer systems due to the possibility that the device may not adequately transfer concentrated medication from a vial to an IV bag before infusion into a patient's vein. If inadequate transfer occurs, the drug delivered to the patient may have variable or unpredictable dosing, which means that a patient may be infused with an overdose or under-dose of medication, leading to life-threatening adverse health consequences.

Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results

Terrific Care, LLC. / Medex Supply is recalling the Roche Diagnostics CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. The test strips may provide results that are higher than the actual INR. Because of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots. Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, atrial fibrillation (irregular heartbeat) who are at an elevated risk of stroke, or those who had a recent blood clot.

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