Reported Apr 29, 2015 · Terminated
Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series…
Del Mar Reynolds Medical, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Del Mar Reynolds Medical, Ltd. · 1 2 Harforde Court John Tate Road · Hertford · N/A
Is this the product you have?
- Spacelabs Pediatric Flow Sensor Kit
- PN376-0561-00. 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
- Lot codes and dates
- PN376-0561-00
- Amount recalled
- 1040 units total (398 in the US and 642 international)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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