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Annual Perioperative Surgical Home Summit

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FDA MEDWATCH ALERTS

December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter

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FDA MedWatch Recall - Particulate Matter

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

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FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled

Summary:

Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled

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Self-Education and Evaluation (SEE) Program

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Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall

Friday, May 07, 2010

Audience: Hospital Risk Managers

FDA and Teleflex Medical notified healthcare professionals of a worldwide voluntary recall affecting certain lot numbers of the Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (HCH) (catalog number 1570), a passive humidifier indicated for use to effectively warm and humidify inspired gas during mechanical ventilation. The 22cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector. This may result in the product becoming disconnected from the patient ET tube. Device failure is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the AQUA+FLEX tubing is connected. No injuries have been reported to date. However, a disconnected tube in ventilator dependent patients without prompt response to the alarm could lead to serious injury or death. Refer to the firm press release for a complete list of affected lot numbers. 

Read the complete MedWatch 2010 Safety alert including a link to the firm press release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211153.htm

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