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U.S. Department of Health and Human Services

Class 1 Device Recall BleaseFocus Anesthesia Workstations

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 Class 1 Recall
BleaseFocus Anesthesia Workstations
see related information
Date Posted March 20, 2013
Recall Status1 Terminated on May 14, 2013
Recall Number Z-0968-2013
Recall Event ID 64535
Premarket Notification
510(K) Numbers
K003251  K101850 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and 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. Anesthesia workstation for use in the hospital environment and locations not requiring portability.
Code Information serial numbers: ABSO-004448, ABSO-004458, ABSO-004459, ABSO-004460, ABSO-004461, ABSO-004462, ABSO-004463, ABSO-004465, ABSO-004466, ABSO-004467, ABSO-004468, ABSO-004469, ABSO-004470, ABSO-004471, ABSO-004472, ABSO-004473, ABSO-004474, ABSO-004475, ABSO-004476, ABSO-004477, ABSO-004478, ABSO-004479, ABSO-004480, ABSO-004481, ABSO-004482, ABSO-004483, ABSO-004487, ABSO-004488, ABSO-004489, ABSO-004490, ABSO-004491, ABSO-004492, ABSO-004493, ABSO-004494, ABSO-004495, ABSO-004497, ABSO-004499, ABSO-004500, ABSO-004503, ABSO-004504, ABSO-004505, ABSO-004506, ABSO-004507, ABSO-004508, ABSO-004510, ABSO-004511, ABSO-004512, ABSO-004513, ABSO-004526, ABSO-004528, ABSO-004529, ABSO-004530, ABSO-004531, ABSO-004532, ABSO-004533, ABSO-004534, ABSO-004535, ABSO-004536, ABSO-004537, ABSO-004538, ABSO-004539, ABSO-004540, ABSO-004541, ABSO-004542, ABSO-004543, ABSO-004544, ABSO-004545, ABSO-004564, ABSO-004566, ABSO-004567, ABSO-004568, ABSO-004569, ABSO-005883, ABSO-005884, ABSO-005885, ABSO-005886, ABSO-005887, ABSO-005945, ABSO-005947, ABSO-005948, ABSO-005949, ABSO-005950, ABSO-100023, ABSO-100024, ABSO-100038, ABSO-100039, ABSO-100040, ABSO-100041, ABSO-100042, ABSO-100043, ABSO-100070, ABSO-100071, ABSO-100072, ABSO-100073, ABSO-100074, ABSO-100075, ABSO-100076, ABSO-100077, ABSO-100078, ABSO-100079, ABSO-100080, ABSO-100081, ABSO-100082, ABSO-100083, ABSO-100084, ABSO-100085, ABSO-100086, and ABSO-100087. Firm added ABSO 004581 - which was inSpacelaabs inventory, in transit to a Field Service Engineer, at the time the recall was initiated. the nonconforming absorber has been replaced with a conforming part and this absober serial number was added to the US Spacelabs Recall tracking. Five incorrect serialnumbers were included in the original serial numbers provided to FDA. This was a result of a data entry error. An updated US and Rest of the World customer/Serial number was provided to FDA 3/25/2013. The correction to the Rest of the World report is as follows: Incorrect SN Reported to FDA Correct, Nonconforming SN ABSO 005883 ABSO-004514 ABSO 005884 ABSO-004515 ABSO 005885 ABSO-004516 ABSO 005886 ABSO-004517 ABSO 005887 ABSO-004518
Recalling Firm/
Manufacturer
Del Mar Reynolds Medical, Ltd.
1-2 Harforde Ct., Foxholes
Business Park
Hertford
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Technical Support
800-522-7025
Manufacturer Reason
for Recall
A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Spacelabs sent an URGENT-MEDICAL DEVICE CORRECTION letter, dated 16 January 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers until a Spacelabs representative replaces the affected product: 1) Immediately cease the use of BleaseSirius and BleaseFocus Anesthesia Workstations that shipped after 31 October 2012. 2) 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 such Service Kit. 3) Advise your staff of this situation Customers can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical support.
Quantity in Commerce 108 total (17 units in the US and 91 units outside the US)
Distribution Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = BLEASE MEDICAL EQUIPMENT LTD.
510(K)s with Product Code = CBK and Original Applicant = SPACELABS HEALTHCARE LTD.
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