Notice: Get a jump on 2015 — Pay your 2015 ASA membership dues now!




January 23 - 25 2015, 12:00 AM - 12:00 AM


February 07 - 08 2015, 12:00 AM - 12:00 AM

ASA Certificate in Business Administration 2015

June 26 - 28 2015, 12:00 AM - 12:00 AM

Annual Perioperative Surgical Home Summit



December 18, 2014

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


FDA MedWatch Recall - Particulate Matter

November 21, 2014

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


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


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



Add this product to your shopping cart

Self-Education and Evaluation (SEE) Program

SKU: 30701-14CE

... Read more »

Single Copies, Member Price: $360

CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation

Friday, December 23, 2011

AUDIENCE: Risk Manager, Anesthesiology, Critical Care

ISSUE: FDA notified health care professionals of a class I recall of CareFusion AVEA Ventilators. The AVEA ventilator can develop a failure where the ventilator activates a false extended high peak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury or death.

BACKGROUND: The AVEA ventilator is intended for continuous breathing support for the care of neonatal through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care institutions. The recalled ventilators were manufactured between March 1, 2009 and June 30, 2011. 

RECOMMENDATION: CareFusion's Recall Support Center is contacting customers to arrange for onsite remediation of the affected devices.

Customers were instructed to follow these steps if any AVEA ventilator in their facility exhibits a sustained extended high peak alarm followed by the opening of the safety valve:

1. Remove the ventilator from service
2. Provide alternate ventilation
3. Contact CareFusion Technical Support at 1-800-231-2466 to report the issue

Read the MedWatch alert, including a link to the Class I Recall Notice, at:


« Back to FDA Alerts and Recalls