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U.S. Department of Health and Human Services

Class 2 Device Recall MODEL 520A NOVAMETRIX PULSE OXIMETER

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  Class 2 Device Recall MODEL 520A NOVAMETRIX PULSE OXIMETER see related information
Date Initiated by Firm May 13, 2009
Date Posted June 28, 2009
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-1559-2009
Recall Event ID 52041
510(K)Number K913516  
Product Classification Oximeter - Product Code DQA
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.
Code Information Lot Number: 26020906, 27020906, 17040906, 21040906 and 22040906.
Recalling Firm/
Manufacturer		 Dixtal Medical, Inc.
101 N Plains Industrial Rd Bldg 2
Wallingford CT 06492-2360
For Additional Information Contact SAME
203-269-1112 Ext. 226
Manufacturer Reason
for Recall		 Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.
FDA Determined
Cause 2		 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 in Commerce 27 Boxes (Packaged 25 sensors/box)
Distribution Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = NOVAMETRIX MEDICAL SYSTEMS, INC.
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