Medical Devices

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

Recall Class: Class I

Date Recall Initiated: Oct. 17, 2013

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.

Public Contact: Customers with questions may contact Spacelabs Healthcare at 1-800-522-7025, select 2 for Technical Support.

FDA District: Seattle District Office

FDA Comments:

On Nov. 1, 2013, Spacelabs Healthcare sent an Urgent Medical Device Correction letter to all affected customers. Spacelabs Healthcare also sent a customer letter (translated as necessary) to all international subsidiaries and distributors of record by e-mail on Nov. 6, 2013. The letter informed customers of a potential defect in CAS I/II Absorber products employed in the Spacelabs Healthcare BleaseSirius 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. In the worst case, this would result in a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode. Operation in vent mode along with all monitoring and alarm functions will continue to operate normally.

Customers were instructed to immediately advise their staff of the problem.

Customers with questions were instructed to contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Page Last Updated: 11/26/2013
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