CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia… — Class I medical device recall Z-0352-2014
Terminated recall by Del Mar Reynolds Medical, Ltd., reported 2013-11-27, distributed nationwide. Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-0
| Recall number | Z-0352-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Del Mar Reynolds Medical, Ltd., Hertford, United Kingdom |
| Recall initiated | 2013-10-17 |
| Classified | 2013-11-20 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | FI, JO, MX, TW |
| Reason classes | device malfunction |
| Serial numbers | 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, ABSO-100135 |
| Model numbers | 050-0659-00, 050-0901-00, 12200900 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0352-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.