Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters.
FDA Recall Z-1559-2009 · Posted 2009-06-28
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Recalling FirmDixtal Medical, Inc.
Recall StatusTerminated
Product CodeDQA
Date Initiated2009-05-13
Date Terminated2012-03-23
Product Quantity27 Boxes (Packaged 25 sensors/box)
Reason for Recall
Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.
Firm Action
Urgent Product Recall Notification was issued to affected accounts by email/facsmile on May 8, 2009 requesting to cease distribution, quarantine and return recalled product. Contact Dixtal Medical with questions; to inquire about your on-hand inventory; or to arrange to receive replacement product at Customer Service: [email protected], Phone Number 1-203-269-1112, Fax Number 1-203-269-1760.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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