Z-0650-2014 Class II Terminated
FDA device recall Z-0650-2014 was initiated by Nova Biomedical Corporation on October 10, 2013 and is designated Class II. Reason for recall: Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage The recall status is terminated (terminated March 24, 2014). Affected quantity: est. 200,000.
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2014
- Initiation Date
- October 10, 2013
- Termination Date
- March 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- est. 200,000
Product Description
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.
Reason for Recall
Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Distribution Pattern
Nationwide Distribution.
Code Information
All serial numbers