The BleaseSirius and BleaseFocus Anaesthesia Systems.

FDA device recall Z-1408-2010 · posted 2010-04-16 · Terminated

Recall details

Recalling firm

Blease Medical Equipment, Ltd.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

BSZ

Quantity affected

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.

Date initiated

2010-03-26

Date posted

2010-04-16

Date terminated

2011-08-23

Location

Chesham Bucks, England, United Kingdom

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