Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital
FDA device recall Z-1472-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Nova Biomedical Corporation
- Reason for recall
- Lithium batteries may fail if the glucose or creatinine meters have been dropped.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 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
- Date initiated
- 2008-02-21
- Date posted
- 2008-09-23
- Date terminated
- 2008-10-28
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS (K070068) | Nova Biomedical Corp. | 2007-05-07 |
| NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS (K060345) | Nova Biomedical Corp. | 2006-04-28 |