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U.S. Department of Health and Human Services

Class 2 Device Recall Anesthesia system

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  Class 2 Device Recall Anesthesia system see related information
Date Initiated by Firm March 26, 2010
Date Posted April 16, 2010
Recall Status1 Terminated 3 on August 23, 2011
Recall Number Z-1408-2010
Recall Event ID 55177
510(K)Number K051629  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product The BleaseSirius and BleaseFocus Anaesthesia Systems.
Code Information Serial numbers:  Siri 000116, Siri 000885, Siri 001100, Siri 001609, Siri 001610, Siri-001618, Siri-001626, Siri-001637, Siri-001640, Siri-001644, Siri-001658, Siri-001666, Siri-001667, Siri-001668, Siri-001674, AND Siri-001681.  Focu-000735, Focu-000737, Focu-000738, Focu-000739, Focu-000740, Focu-000741, Focu-000742, Focu-000743, Focu-000744, Focu-000745, Focu-000746, Focu-000747, Focu-000748, Focu-000749, Focu-000750, Focu-000751, Focu-100001, Focu-100003, Focu-100004, Focu-100005, Focu-100006, Focu-100007, Focu-100008, AND Focu-100009.
Recalling Firm/
Manufacturer		 Blease Medical Equipment, Ltd.
Deansway, Chesham
Bucks, England United Kingdom
For Additional Information Contact Al Van Houdt
425-657-7200
Manufacturer Reason
for Recall		 Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. The vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected.
FDA Determined
Cause 2		 Other
Action On 2/26/2010 notification letters were sent to all international consignees. The 2 domestic consignees were sent notification letters via FEDEX on 3/26/2010. The domestic consignees were also contacted by phone on 3/26/2010. The notification letter is titled URGENT MEDICAL DEVICE CORRECTION. It advises users of the issue and provides additional information which would permit the continued use of the Blease system until replacement back bar valves can be fitted by the recalling firm's service representatives. For users who choose to continue to use the device, the manufacturer recommends the use of an Agent Monitor and user education; also checks that vapourisers have been mounted correctly and the system is leak free, and testing in advance of a procedure. For additional questions, US Customers are directed to call Global Technical Support - +1 425-657-7200 ext: 5089. Non US Customers, call Global Technical Support - +44 1494 784422.
Quantity in Commerce 40 units
Distribution Distributed to 2 U.S. hospitals and to customers in the following countries: Panama, Poland, Australia, Singapore, United Kingdom, Bangladesh, Nicaragua, Vietnam, Argentina, Finland, and Columbia.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = BLEASE USA, INC.
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