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.

Recall Insight

This FDA Devices action (record #Z-1458-2015) was formally reported on April 29, 2015, with the manufacturer initiating the action on March 5, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Del Mar Reynolds Medical, Ltd. is listed as the recalling firm, operating out of Hertford. Federal records indicate 1040 units total (398 in the US and 642 international) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: 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 actu… Distribution data in the federal record shows the product reached: Worldwide Distribution-US including the states of Louisiana, North Carolina, and Washington and the countries of Argentina, Brazil, China, Colombia, Ecuador, Finland, Great Britain, India, Libya, Mexico, Nicaragua, Oman…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.