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.
FDA Recall Z-1472-2008 · Posted 2008-09-23
Advertisement
Recalling FirmNova Biomedical Corporation
Recall StatusTerminated
Product CodeCGA
Date Initiated2008-02-21
Date Terminated2008-10-28
Product Quantity4432 batteries
Reason for Recall
Lithium batteries may fail if the glucose or creatinine meters have been dropped.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement