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U.S. Department of Health and Human Services

Class 2 Device Recall Nova StatStrip/StatSensor Hospital Blood Glucose Meter

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  Class 2 Device Recall Nova StatStrip/StatSensor Hospital Blood Glucose Meter see related information
Date Initiated by Firm October 10, 2013
Date Posted January 09, 2014
Recall Status1 Terminated 3 on March 24, 2014
Recall Number Z-0650-2014
Recall Event ID 66398
510(K)Number k060345  k063821  k070068  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter,

Rechargeable Lithium Batteries
Single: 46626; 4 Pack: 46827; 5 Pack: 50436.

For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453
For Additional Information Contact
781-647-3700
Manufacturer Reason
for Recall		 Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
FDA Determined
Cause 2		 Component design/selection
Action On November 18, 2013, an URGENT Field Correction Letter was sent to all StatStrip Glucose Hospital meter, StatStrip Lactate Hospital Meter and StatSensor Creatinine Hospital Meter customers via email to the Point of Care Coordinator to alert users that lithium batteries that are utilized beyond their intended useful life may swell and/or crack posing a potential safety hazard. In some cases, the swelling may potentially cause the battery door on the meter to dislodge and render the meter inoperable.
Quantity in Commerce est. 200,000
Distribution Nationwide Distribution.
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 = CGA and Original Applicant = NOVA BIOMEDICAL CORP.
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