Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single P
FDA device recall Z-1559-2009 · posted 2009-06-28 · Terminated
Recall details
- Recalling firm
- Dixtal Medical, Inc.
- Reason for recall
- Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 27 Boxes (Packaged 25 sensors/box)
- Distribution
- Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey.
- Date initiated
- 2009-05-13
- Date posted
- 2009-06-28
- Date terminated
- 2012-03-23
- Location
- Wallingford, CT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL 520A NOVAMETRIX PULSE OXIMETER (K913516) | Novametrix Medical Systems, Inc. | 1991-11-04 |