CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Ane...
FDA Device Recall #Z-0352-2014 — Class I — October 17, 2013
Recall Summary
| Recall Number | Z-0352-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | October 17, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Del Mar Reynolds Medical, Ltd. |
| Location | Hertford |
| Product Type | Devices |
| Quantity | 37 units (19 in the US and 18 International) |
Product Description
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.
Lot / Code Information
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.
Other Recalls from Del Mar Reynolds Medical, Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2093-2017 | Class II | Spacelabs Healthcare Arkon Anesthesia Delivery ... | Apr 14, 2017 |
| Z-1460-2017 | Class II | Arkon Anesthesia Delivery System, Model 99999. ... | Feb 8, 2017 |
| Z-1458-2015 | Class II | Spacelabs Pediatric Flow Sensor Kit, PN: 376-05... | Mar 5, 2015 |
| Z-1442-2014 | Class I | SpaceLabs Arkon Anesthesia Delivery System with... | Mar 10, 2014 |
| Z-1771-2013 | Class II | Spacelabs ARKON Anesthesia Workstation. Spa... | Jun 7, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.