Z-1472-2008

Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip...

Name: Z-1472-2008 Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip...
Creator: Nova Biomedical Corporation
Published: 2008-02-21
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2008-02-21 / Terminated / root cause: design

FDA source

Nova Biomedical Corporation began a recall of Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical... on 2008-02-21. The reason FDA records is "Lithium batteries may fail if the glucose or creatinine meters have been dropped". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1472-2008
Status: Terminated
Initiated: 2008-02-21
Posted: 2008-09-23
Terminated: 2008-10-28
Recalling firm: Nova Biomedical Corporation
Product: Varta 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.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Lithium batteries may fail if the glucose or creatinine meters have been dropped.
Root cause tag: design
FDA root cause: Component design/selection
Action: Nova 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 commerce: 4432 batteries
Distribution: Worldwide 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.
Product codes and lots: 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.

Product code CGA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)