FDA Device recall Z-1458-2015
Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00 by Del Mar Reynolds Medical, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1458-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-05 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Del Mar Reynolds Medical |
| Distribution | LA, NC, WA |
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.
Reason
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.
Identifiers
| code_info | PN: 376-0561-00. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1458-2015%22
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