CLASS I Device recall · Reported 27 Nov 2013 · FDA Enforcement Report
CAS I/II Absorbers that are parts of the BleaseSirius recalled
Del Mar Reynolds Medical is recalling CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the, distributed nationwide in the US. The recall was initiated on 17 Oct 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-0352-2014
- FDA event ID
- 66721
- Recalling firm
- Del Mar Reynolds Medical, Hertford
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Oct 2013
- FDA classified
- 20 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 17 Oct 2013 | Recall initiated by company | |
| 20 Nov 2013 | Classified by FDA | +34 days |
| 27 Nov 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
Spacelabs Healthcare Ltd. of United Kingdom recalls , 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.
Product as listed by the FDA
CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of 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 for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
Where it was distributed
Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.
Questions about this recall
Why was it recalled?
Spacelabs Healthcare Ltd. of United Kingdom recalls , 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.
Which lots are affected?
SERIAL NUMBERS IN THE US: ABSO-001754, ABSO-004081, ABSO-100111, ABSO-100112, ABSO-100113, ABSO-100114, ABSO-100117, ABSO-100120, ABSO-100121, ABSO-100122, ABSO-100123, ABSO-100124, ABSO-100125, ABSO-100126, ABSO-100127, ABSO-100128, ABSO-100132, ABSO-100134, and ABSO-100135. SERIAL NUMBERS INTERNATIONAL: ABSO-100098, ABSO-100099, abso-100100, ABSO-100101, abso-100102, ABSO-100103, abso-100104, abso-100105, abso-100106, ABSO-100107, ABSO-100108, ABSO-100109, ABSO-100110, ABSO-100129, ABSO-100130, ABSO-100131, ABSO-100136, AND ABSO-100137.
Where was it sold?
Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, 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
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|---|---|---|---|---|---|
| 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 |
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