| Class 1 Device Recall AVEA Ventilator | |
Date Initiated by Firm | September 08, 2011 |
Date Posted | January 11, 2012 |
Recall Status1 |
Terminated 3 on October 29, 2013 |
Recall Number | Z-0510-2012 |
Recall Event ID |
60148 |
510(K)Number | K013642 K073069 K103211 |
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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Product | AVEA Ventilator (Catalog Code 17310, 17311, 17312).
The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician. |
Code Information |
Catalog Code 17310, 17311, 17312 (each of the affected devices is individually seralized) |
Recalling Firm/ Manufacturer |
Carefusion 211 Inc 22745 Savi Ranch Pkwy Yorba Linda CA 92887-4668
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For Additional Information Contact | Jim Mazzola 858-617-1203 |
Manufacturer Reason for Recall | The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | CareFusion sent an "URGENT PRODUCT RECALL" letter dated September 25, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers were instructed to contact the firm by telephone to coordinate implementation of the corrective action at their site. Customers were instructed to return an enclosed response card to expedite the correction process and acknowledge receipt of the recall notification. Carefusion does not require that the customers return their devices. Customers will be contacted by a member of the CareFusion Technical Support Department to arrange for onsite remediation of the affected devices. In the interim, if any affected AVEA ventilator units in their facility exhibits a sustained Extended High Ppeak alarm followed by the opening of the Safety Valve, customers were instructed to remove the ventilator from service, provide alternate ventilation and contact Carefusion Technical Support (800) 213-2466 to report the issue. All ventilator dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction were to occur, alternate ventilation can be provided. |
Quantity in Commerce | 6797 total, 1891 in US, 4906 worldwide |
Distribution | Worldwide Distribution-USA (nationwide) and the countries of Cyprus, Estonia, Brazil, Kuwait, United Arab Emirates, Slovenia, Lithuania, Latvia, Belgium, Bermuda, Ecuador, Guatemala, Italy, Canada, Australia, Netherlands, Germany, United Kingdom, Spain, Czech (Rep), Nicaragua, China, Bangladesh, Morocco, Bolivia, Vietnam, Slovakia, Paraguay, Argentina, Turkey, Chile, Singapore, Japan, Colombia, Egypt, Hong Kong, Honduras, India, Croatia, Venezuela, Saudi Arabia, Greece, Hungary, Mexico, Austria, Ireland,Indonesia, Dominican Republic, Portugal, South Africa, Panama, Philippines, Libyan Jamahiriya, Jordan, Malaysia, France, Thailand, Peru, Costa Rica, Korea, and Taiwan. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CBK 510(K)s with Product Code = CBK 510(K)s with Product Code = CBK
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