Spacelabs Anesthesia Workstations and Service Kits: Class 1 Recall - Defect in CAS I/II Absorbers

March 26, 2013

Audience: Anesthesiology, Biomedical Engineering, Risk Managers

 

[Posted 03/26/2013]

 

ISSUE:  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. These products were manufactured and distributed from Oct. 31, 2012 to Jan. 15, 2013.

BACKGROUND: 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.

RECOMMENDATION:   Immediately cease use of BleaseSirius and BleaseFocus Anesthesia Workstations shipped after Oct. 31, 2012. 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. Advise staff of this situation. Customers may call Spacelabs Medical at 1-800-522-7025 and select 2 for Technical support.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[03/26/2013 - Recall Notice - FDA]

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