CLASS II Device recall · Reported 29 Apr 2015 · FDA Enforcement Report

Spacelabs Pediatric Flow Sensor Kit, PN recalled

Del Mar Reynolds Medical is recalling Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00, distributed in Louisiana, North Carolina, Washington. The recall was initiated on 5 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPN: 376-0561-00.

Quantity recalled1040 units total (398 in the US and 642 international)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1458-2015
FDA event ID: 70754
Recalling firm: Del Mar Reynolds Medical, Hertford
Classification: Class II
Status: Terminated
Recall initiated: 5 Mar 2015
FDA classified: 20 Apr 2015
Reported: 29 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: CPAP & Ventilators

Timeline

5 Mar 2015	Recall initiated by company
20 Apr 2015	Classified by FDA	+46 days
29 Apr 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Louisiana North Carolina Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

PN: 376-0561-00.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Del Mar Reynolds Medical

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Reported	Class	Recall	Company	Reason	Where
24 May 2017Device	CLASS II	Spacelabs Healthcare Arkon Anesthesia Delivery System recalled	Del Mar Reynolds Medical	Packaging Defects	6 states
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23 Apr 2014Device	CLASS I	SpaceLabs Arkon Anesthesia Delivery System recalled	Del Mar Reynolds Medical	Device Malfunction	Nationwide
27 Nov 2013Device	CLASS I	CAS I/II Absorbers that are parts of the BleaseSirius recalled	Del Mar Reynolds Medical	Other	Nationwide
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