Recall Z-1559-2009 ยท DQA Oximeter
Dixtal Medical, Inc.
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.
| Date | Jun 28, 2009 (initiated May 13, 2009) |
| Status | Terminated |
| Reason | Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors. |
| 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: sales@dixtal.com, Phone Number 1-203-269-1112, Fax Number 1-203-269-1760. |
| Quantity | 27 Boxes (Packaged 25 sensors/box) |
| Distribution | Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913516 | MODEL 520A NOVAMETRIX PULSE OXIMETER Novametrix Medical Systems, Inc., Nov 4, 1991 |