CLASS I Device recall · Reported 27 Mar 2013 · FDA Enforcement Report
Spacelabs BleaseSirius Anesthesia Workstation recalled
Del Mar Reynolds Medical is recalling Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and, distributed nationwide in the US. The recall was initiated on 15 Jan 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0968-2013
- FDA event ID
- 64535
- Recalling firm
- Del Mar Reynolds Medical, Hertford, N/A
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Jan 2013
- FDA classified
- 20 Mar 2013
- Reported
- 27 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Jan 2013 | Recall initiated by company | |
| 20 Mar 2013 | Classified by FDA | +64 days |
| 27 Mar 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Del Mar Reynolds Medical
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Spacelabs Healthcare Arkon Anesthesia Delivery System recalled | Del Mar Reynolds Medical | Packaging Defects | 6 states |
| Device | CLASS II | Arkon Anesthesia Delivery System recalled by Del Mar Reynolds Medical | Del Mar Reynolds Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Spacelabs Pediatric Flow Sensor Kit, PN recalled | Del Mar Reynolds Medical | Labeling Errors | LA, NC, WA |
| Device | CLASS I | SpaceLabs Arkon Anesthesia Delivery System recalled | Del Mar Reynolds Medical | Device Malfunction | Nationwide |
| Device | CLASS I | CAS I/II Absorbers that are parts of the BleaseSirius recalled | Del Mar Reynolds Medical | Other | Nationwide |
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