Recalls

Anesthesia kits recalled, defect could be deadly to patients

fda logo Anesthesia kits recalled, defect could be deadly to patientsSpacelabs anesthesia workstations and service kits are being recalled because of a defect that can be deadly to patients. The problem is with the CAS I/II Absorbers on the devices, which can cause an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. This defect may cause serious adverse health consequences, including death.

These anesthesia workstations are used in hospitals and in places 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 anesthesia vapor.

Customers have been asked to immediately stop using the BleaseSirius and BleaseFocus Anesthesia Workstations shipped after Oct. 31, 2012. They should 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 and advise staff of this situation. Customers may call Spacelabs Medical at 1-800-522-7025 and select 2 for Technical support.

Health care professionals and patients are encouraged to report any side effects associated with this product to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA