Z-1559-2009

Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap...

Name: Z-1559-2009 Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap...
Creator: Dixtal Medical, Inc.
Published: 2009-05-13
License: https://open.fda.gov/license/

Dixtal Medical, Inc. / initiated 2009-05-13 / Terminated / root cause: labeling and UDI

FDA source

Dixtal Medical, Inc. began a recall of 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... on 2009-05-13. The reason FDA records is "Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1559-2009
Status: Terminated
Initiated: 2009-05-13
Posted: 2009-06-28
Terminated: 2012-03-23
Recalling firm: Dixtal Medical, Inc.
Product: 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.
Product code: DQA Oximeter
Reason for recall: Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 27 Boxes (Packaged 25 sensors/box)
Distribution: Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey.
Product codes and lots: Lot Number: 26020906, 27020906, 17040906, 21040906 and 22040906.

Product code DQA

K913516Class IIModel 520A Novametrix Pulse OximeterNovametrix Medical Systems, Inc. / cleared 1991-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)