FDA Alerts

Class 1 Recall: Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits - Bag-to-Vent Switch in CAS I/II Absorbers May Fail

here is a potential defect in the CAS I/II Absorber products employed in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00.

Thu Oct 17 2013By Kaylee McCaffrey

Products: CAS I/II Absorbers installed in the BleaseSirius and BleaseFocus Anesthesia Workstations with the following part numbers: 12200900, 12200901, 12200902, 12200903, 14200100 and Service Kits Part Number 050-0659-00 and 050-0901

These products were manufactured from Feb. 21, 2013 through September 30, 2013

Use: 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.

Recalling Firm:
Spacelabs Healthcare, Inc.
35301 SE Center Street
Snoqualmie, Washington 98065

Manufacturer: 
Del Mar Reynolds Medical, Ltd.
1-2 Harforde Ct., Foxholes Business Park
Hertford, United Kingdom

Reason for Recall: There is a potential defect in the CAS I/II Absorber products employed in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber. The affected products may cause serious adverse health consequences, including death.

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