VentStar Oxylog Breathing Circuit Recall [US]


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US/Silver Spring: VentStar Oxylog Breathing Circuit Recall [US]Dräger recalls an estimated 1,530 VentStar Oxylog 3000 Pediatric Patient Breathing Circuits due to suspected valve leakage and resultant excessive carbon dioxide in the bloodstream (Hypercapnia) and increased acidity in the blood (Acidosis), both of which could lead to premature death. FDA: http://ht.ly/ol7V303mIKX

Direct link: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm515107.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Medical Devices are subject to this recall:

  • VentStar Oxylog 3000 Disposable Pediatric Patient Circuit
    Catalog number: 5704964
    Manufacturing dates: May 2013 to March 2016
    Distribution dates: May 2013 to March 2016

Please consult the photograph above for details of the food’s packaging, design and retail presentation. One (1) additional image of the recalled Breathing Circuit is pictured on the Web site above.

According to the FDA, an estimated 1,530 of the recalled Pediatric Patient Breathing Circuits were sold throughout the United States, including in Alaska, California, Florida, Indiana, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.

The VentStar Oxylog 3000 Disposable Pediatric Patient Breathing Circuits are used with the Dräger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators for pediatric patients who require ventilation.

The primary users of this device are doctors, nurses, emergency medical technicians, respiratory therapists and paramedics. Use environments include during vehicular transport, within emergency departments or in the recovery room.

Dräger reports it discovered the check valve on the recalled Circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels. This, in turn, can lead to serious health consequences, including excessive carbon dioxide in the bloodstream (Hypercapnia) and increased acidity in the blood (Acidosis). Both of these conditions can lead to pediatric death.

Note: This issue pertains only to the VentStar Oxylog 3000 Disposable Pediatric Patient Circuit. There is no issue or problem with the Oxylog 3000/3000 plus Ventilator.

If you believe you have purchased or have in your possession any of the recalled Breathing Circuits, please do not use them until a Dräger representative examines and replaces or repairs the affected device. Dräger is contacting registered owners of these recalled medical devices.

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Additional information about this recall:
Recalls Direct RIN: 7460-2016
More recalls? Back to the main Recalls Direct page: http://www.RecallsDirect.com/
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org/
E. & O. E.

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