Recall Z-0968-2013 ยท CBK Ventilator, Continuous, Facility Use
Del Mar Reynolds Medical, Ltd.
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.
| Date | Mar 20, 2013 (initiated Jan 15, 2013) |
| Status | Terminated |
| Reason | A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient. |
| Root cause | Process control |
| Action | Spacelabs sent an URGENT-MEDICAL DEVICE CORRECTION letter, dated 16 January 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers until a Spacelabs representative replaces the affected product: 1) Immediately cease the use of BleaseSirius and BleaseFocus Anesthesia Workstations that shipped after 31 October 2012. 2) Immediately cease use of Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a CAS I/II Absorber from such Service Kit. 3) Advise your staff |
| Quantity | 108 total (17 units in the US and 91 units outside the US) |
| Distribution | Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan. |
| FDA record | Open on fda.gov |