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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Related recalls
Same manufacturer · Del Mar Reynolds Medical, Ltd.
See all →- HighSpacelabs Arkon Anesthesia Delivery System Canister Carrier Recall
FDA (Devices) · 2017-05-24
- SevereArkon Anesthesia Delivery System Recalled for Unannounced Power Supply Failure
FDA (Devices) · 2017-03-22
- SevereSpaceLabs Arkon Anesthesia Delivery System Recalled for Software Failure
FDA (Devices) · 2014-04-23
- SevereSpacelabs recalls anesthesia workstation absorbers due to potential switch failure
FDA (Devices) · 2013-11-27
- ModerateSpacelabs ARKON Anesthesia Workstation Recalled for Software Defect
FDA (Devices) · 2013-07-31
Same hazard · inaccurate reading
See all →- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateDel Mar Reynolds Medical Recalls BleaseFocus Anesthesia Workstations Due to Manual Error
FDA (Devices) · 2012-12-26
- HighHamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements
FDA (Devices) · 2015-07-08
- HighSpacelabs Arkon Anesthesia Delivery System Canister Carrier Recall
FDA (Devices) · 2017-05-24
- HighSpacelabs Ventilator Interface Recalled for Minute Volume Display Error
FDA (Devices) · 2014-06-25
- SevereVentlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07
- SevereVentlab Infant Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07