Del Mar Reynolds Medical, Ltd.: Medical Device Recall in 2015 - (Recall #: Z-1458-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: March 5, 2015

Date Posted: April 29, 2015

Recall Number: Z-1458-2015

Event ID: 70754

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.

Status: Terminated

Product Quantity: 1040 units total (398 in the US and 642 international)

Code Information:

PN: 376-0561-00.

Distribution Pattern:

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, Philippines, Saudi Arabia, Slovakia, Sri Lanka, United Arab Emirates, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated