Blease Medical Equipment, Ltd.
Country not established
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Blease Medical Equipment, Ltd. makes
Blease Medical Equipment, Ltd. manufactures anesthesia ventilators and anesthesia machines, including the Blease 6200 Anesthesia Ventilator, Blease Frontline Genius Range Anesthesia Machines, Blease Frontline Plus Range Anesthesia Machines (Models 440, 560, and 690), and Blease Sirius Anesthesia System (Models 3000 and 2000).
The company's products are listed in the FDA 510(k) registry and are classified as Class II medical devices. Blease Medical Equipment, Ltd. is based in the US.
Catalogue
Blease 6200 Anaesthesia Ventilator Ref K982132
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Blease Medical Equipment, Ltd., initiated on 2010-03-26. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 26 Mar 2010 Z-1408-2010 Unclassified (pre-2012) Terminated Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. The vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected.
Full distribution text
- 26 Mar 2010 Z-1408-2010 Unclassified (pre-2012) Terminated Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. The vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected.
Frequently asked questions
How many devices does Blease Medical Equipment, Ltd. have in the registry?
The registry currently lists 5 devices for Blease Medical Equipment, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Blease Medical Equipment, Ltd.'s devices?
Among its 5 most recently registered devices, Blease Medical Equipment, Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Blease Medical Equipment, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Blease Medical Equipment, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Blease Medical Equipment, Ltd.?
FDA recall records list 1 recall initiated by Blease Medical Equipment, Ltd., the most recent initiated on 2010-03-26. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Blease Medical Equipment, Ltd. in the registry?
The most recently registered devices listed for Blease Medical Equipment, Ltd. include BLEASE 6200 ANAESTHESIA VENTILATOR, MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES, BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 and BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000.