FDA Medical Device Recalls (openFDA)
Del Mar Reynolds Medical, Ltd.: 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 number
- Z-1458-2015
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2015-03-05
- Posted
- 2015-04-20
- Terminated
- 2015-11-16
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- PN: 376-0561-00.
- 510(k) numbers
- ["K112729"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3002807992
- Firm city
- Hertford
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28