Spacelabs Pediatric Flow Sensor Kit Recalled for Inaccurate Low Flow Readings
Del Mar Reynolds Medical is recalling Spacelabs Pediatric Flow Sensor Kits because they report inspiratory and expiratory tidal volumes lower than the actual volumes delivered to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (ventilator sensor) where inaccurate readings could lead to improper ventilation, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Del Mar Reynolds Medical, Ltd. is recalling the Spacelabs Pediatric Flow Sensor Kit, Part Number 376-0561-00. This kit is designed for Spacelabs Healthcare Blease 700/900 Series Ventilators used for the mechanical ventilation of adult and pediatric patients under general anesthesia.
The recall was initiated due to reports of inaccurate low flow readings. Specifically, the 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.
A total of 1,040 units were distributed worldwide, including 398 units in the United States and 642 units internationally. The affected units were distributed in the US states of Louisiana, North Carolina, and Washington, as well as in Argentina, Brazil, China, Colombia, Ecuador, Finland, Great Britain, India, Libya, Mexico, Nicaragua, Oman, Philippines, Saudi Arabia, Slovakia, Sri Lanka, United Arab Emirates, and Vietnam.
The recalled product
- 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.
- Manufacturer
- Del Mar Reynolds Medical, Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- PN: 376-0561-00.
Distribution
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