Recall Z-0650-2014
Nova Biomedical Corporation · initiated October 10, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All serial numbers
Reason for recall
Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-0650-2014
- Initiated
- October 10, 2013
- Posted by FDA
- January 9, 2014
- Terminated
- March 24, 2014
- Product code
- CGA – Glucose Oxidase, Glucose
- Quantity
- est. 200,000
- Distribution
- Nationwide Distribution.
- Recalling firm
- Nova Biomedical Corporation, Waltham, MA