Recall Z-0968-2013— Del Mar Reynolds Medical, Ltd.
Class I · Terminated
Class I FDA medical device recall by Del Mar Reynolds Medical, Ltd., initiated 2013-01-15, terminated 2013-05-14. It names 2 FDA 510(k) clearances: K101850, K003251. 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.. Reason: 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..
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-01-15
- Terminated
- 2013-05-14
- Firm location
- Hertford, N/A, United Kingdom
510(k) clearances named in this recall
2 on FDA's record- K101850 — SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
- K003251 — BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.