Recall Z-0352-2014 ยท BSZ Gas-Machine, Anesthesia
Del Mar Reynolds Medical, Ltd.
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 a
| Date | Nov 20, 2013 (initiated Oct 17, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated November 1, 2013, to all affected customers. Spacelabs Healthcare also sent a customer letter (translated as necessary) to all international subsidiaries and distributors of record via e-mail on November 6, 2013. The letter informed customers of a potential defect in CAS I/II Absorber products employed in the Spacelabs Healthcare BleaseSirius Anesthesia Workstation, and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag-to-Vent switch in CAS I/II Absorbers may fail. In the worst case, this would result |
| Quantity | 37 units (19 in the US and 18 International) |
| Distribution | Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan. |
| FDA record | Open on fda.gov |