Recall Z-1458-2015— Del Mar Reynolds Medical, Ltd.
Class II · Terminated
Class II FDA medical device recall by Del Mar Reynolds Medical, Ltd., initiated 2015-03-05, terminated 2015-11-16. It names one FDA 510(k) clearance: K112729. Product: 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: 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..
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-05
- Terminated
- 2015-11-16
- Firm location
- Hertford, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.