FDAFDA · Food and drugs·Recall number Z-1458-2015
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.
Published April 29, 2015 · Recall initiated: March 5, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Del Mar Reynolds Medical, Ltd.
- Distributor
- 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.
- Lot
- PN: 376-0561-00.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.