Recall Z-1408-2010 ยท BSZ Gas-Machine, Anesthesia
Blease Medical Equipment, Ltd.
The BleaseSirius and BleaseFocus Anaesthesia Systems.
| Date | Apr 16, 2010 (initiated Mar 26, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 th |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051629 | BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 Blease USA, Inc., Sep 23, 2005 |