• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MODEL 520A NOVAMETRIX PULSE OXIMETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
MODEL 520A NOVAMETRIX PULSE OXIMETER
see related information
Date Posted June 28, 2009
Recall Status1 Open
Recall Number Z-1559-2009
Recall Event ID 52041
Premarket Notification
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, Connecticut 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = NOVAMETRIX MEDICAL SYSTEMS, INC.
-
-