Z-1458-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2015
- Initiation Date
- March 5, 2015
- Termination Date
- November 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1040 units total (398 in the US and 642 international)
Product Description
Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.
Reason for Recall
Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient.
Distribution Pattern
Worldwide Distribution-US including the states of Louisiana, North Carolina, and Washington and the countries of Argentina, Brazil, China, Colombia, Ecuador, Finland, Great Britain, India, Libya, Mexico, Nicaragua, Oman, Philippines, Saudi Arabia, Slovakia, Sri Lanka, United Arab Emirates, and Vietnam.
Code Information
PN: 376-0561-00.