Recall Z-1472-2008
Nova Biomedical Corporation · initiated February 21, 2008
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.
Codes / 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.
Reason for recall
Lithium batteries may fail if the glucose or creatinine meters have been dropped.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-1472-2008
- Initiated
- February 21, 2008
- Posted by FDA
- September 23, 2008
- Terminated
- October 28, 2008
- Product code
- CGA – Glucose Oxidase, Glucose
- Quantity
- 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.
- Recalling firm
- Nova Biomedical Corporation, Waltham, MA