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U.S. Department of Health and Human Services

Class 2 Device Recall Varta EasyPack XL Lithium Polymer Battery (PoLiFlex)

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 Class 2 Device Recall Varta EasyPack XL Lithium Polymer Battery (PoLiFlex)see related information
Date Initiated by FirmFebruary 21, 2008
Date PostedSeptember 23, 2008
Recall Status1 Terminated 3 on October 28, 2008
Recall NumberZ-1472-2008
Recall Event ID 46904
510(K)NumberK060345 K070068 
Product Classification Lithium batteries used in the Glucose and Creatinine Test System - Product Code CGA
ProductVarta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood.
Code Information Batteries coded: XX07 and earlier The Nova Biomedical products that contain the lithium batteries include the following part numbers: Part # 41772 - Battery Assy,  Part # 42215 - Battery Replacement pack,  Part # 42224 - Kit Meter,  Part # 43735 - Kit Meter EZ CHEM,  Part # 43773 - Kit Meter,  Part # 43811 - Battery Replacement Pack EZ CHEM,  Part # 44013 - Kit Meter,  Part # 44014 - Kit Meter and Part # 44251 - Kit Meter.
Recalling Firm/
Manufacturer		 Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453-3457
For Additional Information Contact
781-894-0800 Ext. 211
Manufacturer Reason
for Recall		Lithium batteries may fail if the glucose or creatinine meters have been dropped.
FDA Determined
Cause 2		Component design/selection
ActionNova Biomedical notified consignees by telephone and followed by the Recall Notification letter for the Vata Easy Pack XL Lithium Polymer Battery, dated 2/2108 and mailed 2/26/08. Users are notified of the problem with the battery in the Nova Stat Strip Blood Glucose Hospital Meter System and is replacing batteries by on site visit. E-Z-EM , Inc. notified their customers by letter dated 3/17/08. Contact Nova Biomedical Corporation at 1-800-545-6682 for assistance.
Quantity in Commerce4432 batteries
DistributionWorldwide Distribution --- including USA and countries of Canada, Taiwan, Hungary, Malaysia, Australia, Russia, Thailand, New Zealand, Austria, France, Germany, UK, China, South Africa, Croatian, Peru, and Czech Republic.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CGA
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