Spacelabs Pediatric Flow Sensor Kit — Class II medical device recall Z-1458-2015
Terminated recall by Del Mar Reynolds Medical, Ltd., reported 2015-04-29, distributed in LA, NC, WA. Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume
| Recall number | Z-1458-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Del Mar Reynolds Medical, Ltd., Hertford, United Kingdom |
| Recall initiated | 2015-03-05 |
| Classified | 2015-04-20 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-11-16 |
| Distributed | LA, NC, WA |
| Countries outside the US | AE, AR, BR, CN, CO, EC, FI, GB, IN, LK, MX, NI, OM, PH, SA, SK, VN |
| Reason classes | specification failure |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.