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U.S. Department of Health and Human Services

Class 2 Device Recall Nova Biomedical

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  Class 2 Device Recall Nova Biomedical see related information
Date Initiated by Firm September 22, 2003
Date Posted October 24, 2003
Recall Status1 Terminated 3 on February 04, 2004
Recall Number Z-0060-04
Recall Event ID 27334
510(K)Number K981427  
Product Classification Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
Product Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer)
Part # 20394
Code Information Lot Number Exp. Date  304716 2/29/04  304074 2/29/04  303798 1/31/04  303515 1/31/04  303479 1/31/04  303222 1/31/04  302808 12/31/03  302652 12/31/03  302267 12/31/03  301844 11/30/03  301443 11/30/03  301219 11/30/03  212490 10/31/03  212332 10/31/03  212043 10/31/03  211170 9/30/03 
Recalling Firm/
Manufacturer		 Nova Biomedical Corporation
200 Prospect Street
Waltham MA 02454
For Additional Information Contact Paul MacDonald
781-647-3700 Ext. 211
Manufacturer Reason
for Recall		 Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
FDA Determined
Cause 2		 Other
Action Nova Biomedical contacted customers by telephone beginning on 9/26/03. Each account was faxed or mailed Customer Information Bulletin requesting the discard of Mg++ sensors in inventory that are greater than 4 months old from date of manufacture. Replacement product will be issued.
Quantity in Commerce 659 units
Distribution Natinwide Foreign: Italy, Czech, Japan, Taiwan, Hungary, India, Israel, Mexico, Canada, Germany,Switzerland, Tunisia, Korea, Brazil, Greece, Coatia, China, France, Turkey, Thailand, Argentina. Government: VA Decator, GA
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 = CHL and Original Applicant = NOVA BIOMEDICAL CORP.
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