Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spacelabs Pediatric Flow Sensor Kit Recalled by Del Mar Reynolds Medical, Ltd. Due to Reports of inaccurate low flow readings. Monitored inspiratory...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Del Mar Reynolds Medical, Ltd. directly.
Affected Products
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.
Quantity: 1040 units total (398 in the US and 642 international)
Why Was This 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.
Where Was This Sold?
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.
About Del Mar Reynolds Medical, Ltd.
Del Mar Reynolds Medical, Ltd. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report