Recall Z-1458-2015 ยท CBK Ventilator, Continuous, Facility Use
Del Mar Reynolds Medical, Ltd.
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.
| Date | Apr 20, 2015 (initiated Mar 5, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Vendor change control |
| Action | Spacelabs started mailing the Urgent Medical Device Correction- Pediatric Flow Sensor kit, PN: 376-0561-00 used with Spacelabs 700 and 900 series ventilators letter, dated 17 March 2015, via priority service to all US customers. Spacelabs will be emailing the customer letter (translated as necessary) to all international subsidiaries and distributors of record on March 20, 2015. Customers are asked to dispose of all pediatric flow sensors purchased from Spacelabs (even if they shipped outside of the time frame in which affected product shipped). Customers are requested to complete and retu |
| Quantity | 1040 units total (398 in the US and 642 international) |
| Distribution | 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 Vietn |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112729 | BLEASE700/900 SERIES VENTILATORS Spacelabs Healthcare, Jun 11, 2012 |