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Defective Spacelabs Anesthesia Workstations and Kits Recalled Due to Risk of High Carbon Dioxide Concentrations to Patients Potentially Causing Death


The Spacelabs BleaseSirius Anesthesia Workstation; BleaseFocus Anesthesia Workstation; 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 have been recalled. These products were manufactured and distributed from October 31, 2012, to January 15, 2013.

 

These products are used in the hospital environment and in locations not requiring mobility of the products. They provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to deliver anesthetic vapor.

 

There is a defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits that may cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. This product may cause serious adverse health consequences, including death. The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

Spacelabs has advised customers to immediately cease use of BleaseSirius and BleaseFocus Anesthesia Workstations shipped after October 31, 2012. Customers should also 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 a Service Kit.

 

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