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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Pediatric Flow Sensor Kit

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  Class 2 Device Recall Spacelabs Pediatric Flow Sensor Kit see related information
Date Initiated by Firm March 05, 2015
Date Posted April 20, 2015
Recall Status1 Terminated 3 on November 16, 2015
Recall Number Z-1458-2015
Recall Event ID 70754
510(K)Number K112729  
Product Classification Ventilator, continuous, facility use - Product Code CBK
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.
Code Information PN: 376-0561-00.
Recalling Firm/
Del Mar Reynolds Medical, Ltd.
1 2 Harforde Court John Tate Road
Business Park
Hertford United Kingdom
For Additional Information Contact Technical Support
800-522-7025 Ext. 2
Manufacturer 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.
FDA Determined
Cause 2
Vendor change control
Action Spacelabs started mailing the Urgent Medical Device Correction- Pediatric Flow Sensor kit, PN: 376-0561-00 used with Spacelabs 700 and 900 series ventilators letter, dated 17 March 2015, via priority service to all US customers. Spacelabs will be emailing the customer letter (translated as necessary) to all international subsidiaries and distributors of record on March 20, 2015. Customers are asked to dispose of all pediatric flow sensors purchased from Spacelabs (even if they shipped outside of the time frame in which affected product shipped). Customers are requested to complete and return the Business Reply Form to Spacelabs Healthcare either by fax to Global Tech Support at 425-363-5758 or scan the form and email to techsupport@spacelabs.com Spacelabs will send you at no charge replacement pediatric flow sensors (376-0561-01) for all Spacelabs pediatric flow sensors you purchased. These NEW sensors will be marked with a "-01" molded into the body so you can tell the difference between the old sensors and the new ones. For additional information or technical assistance, please contact: Technical Support Spacelabs Healthcare, Inc. 35301 SE Center Street Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support
Quantity in Commerce 1040 units total (398 in the US and 642 international)
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = SPACELABS HEALTHCARE