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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: PN: 376-0561-00.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Del Mar Reynolds Medical, Ltd.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
PN: 376-0561-00.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1458-2015
Related Recalls
Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery alarms.
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Del Mar Reynolds Medical
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.