Del Mar Reynolds Medical, Ltd. recalls Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventil…

Recall date

March 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1458-2015

FDA classification

Class II

Brand / firm

Del Mar Reynolds Medical, Ltd.

Sold / distributed

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 Viet…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.