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Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and… recallZ-1472-2008 · Nova Biomedical Corporation · initiated Feb 21, 2008

Terminated All recalls posted in September 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nova Biomedical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Lithium batteries may fail if the glucose or creatinine meters have been dropped.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-1472-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 21, 2008
Posted by the FDA
Sep 23, 2008
Recalling firm
Nova Biomedical Corporation
Quantity
4432 batteries
Product code
CGA
FDA submissions
K060345, K070068
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.

Product description

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

3 devices cleared under K060345, K070068 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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