[PDF] Nova Biomedical StatStrip and StatSensor Battery Labeling Field




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[PDF] Nova Biomedical StatStrip and StatSensor Battery Labeling Field

18 nov 2013 · batteries/labels that do not have expiration dates printed on them that help to ensure the batteries are not used beyond their intended 

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[PDF] Nova Biomedical StatStrip and StatSensor Battery Labeling Field 41292_7V19351_FSN.pdf        Nova Biomedical, 200 Prospect Street, Waltham, MA 02454 PRODUCT: Nova StatStrip® and StatSensor® Blood Monitoring Systems FSN NO: 10-13SS-International DATE: November 18, 2013

Nova Biomedical

StatStrip and StatSe

nsor Battery

Labeling Field Safety Corrective Action

Dear Nova StatStrip and StatSensor Customers,

The Lithium rechargeable batteries used in your Nova StatStrip and StatSensor Hospital Meter Systems are designed to provide the highest level of safety, convenience, quality and durability. However, all rechargeable Lithium batteries have a finite useful life. This Field Safety Notice is to alert users that Lithium batteries utilized beyond their intended

useful life may swell and/or crack the external case posing a potential safety hazard. In

some cases, the swelling may cause the battery door on the meter to incorrectly seat

rendering the meter inoperable. Nova Biomedical is recalling StatStrip/StatSensor batteries/labels that do not have expiration dates printed on them that help to ensure the batteries are not used beyond their intended useful life.

Since August 2012, Nova Biomedical has included expiration dates on the upper right hand corner of the battery label for StatStrip/StatSensor batteries; reference Figure 1. Batteries that exceed their expiration date should be removed from point of use and replaced with a new battery upon receipt of replacement batteries from Nova

Biomedical.

Figure 1: Battery Label Expiration Date Location

Page 2 of 2

What to do:

1. Battery Labels Without

Expiration Dates: Nova Biomedical is recalling and replacing all Nova StatStrip and StatSensor batteries without expiration dates on the battery label. If your institute has not already done so, Nova encourages your institute to immediately implement a battery inspection program to identify and remove batteries from point of use that do not have expiration dates on the battery label. During the inspection, if you identify batteries without expiration dates, please contact Nova Biomedical Technical Support or your authorized local distributor to report this finding and request a no-charge replacement. Batteries without expiration dates should be removed from point of use and replaced with new replacement batteries received from Nova Biomedical that have expiration dates printed on them. Batteries removed from point of use should be disposed of in accordance with local regulations.

2. Battery Labels With

Expiration Dates: During this periodic inspection, batteries that exhibit any of the following conditions should also be removed from point of use and properly disposed of in accordance with local regulations: • Swelling • Cracking or damage to the battery case that is indicative of damage • Leakage • Failure to hold a proper charge If you identify batteries that exhibit any of the above failure conditions, that have not exceeded their expiration date, please contact Nova Biomedical Technical Support or your authorized local distributor to document and report this finding and to request a no-charge replacement of your battery. If you have any additional questions or concerns or to arrange for immediate no-charge battery replacements , in Canada contact us at 800-263-5999, outside N. America contact your authorized local Nova distributor. We apologize for this inconvenience and thank you for your current and continued support of Nova Biomedical StatStrip and StatSensor products.

November 18, 2013

FAX-Back/ Email-Back Compliance Response Form

International

Nova StatStrip/StatSensor Battery Labeling Field Safety Corrective Action

Dear Nova StatStrip/StatSensor Customer:

Please complete the following information concerning the Nova StatStrip/StatSensor

Battery Labeling

Field Safety Corrective Action:

Check Statements below:

Yes____No____ I have read and understand the Nova StatStrip/StatSensor Battery Labeling Field Safety Notice, FSN 10-13SS-International, dated November 18, 2013 that Nova Biomedical is recalling and replacing all StatStrip/StatSensor batteries/labels that do not have expiration dates printed on them. Yes____No____ I have implemented a battery inspection program to identify batteries/labels without expiration dates. Yes____No____ I have identified ____ (record number) batteries/labels that do not have an expiration date on them. Record '0' if you do not have any batteries without expiration dates on the battery label. Yes____No____ I have contacted my local distributor to report the number of batteries/labels without expiration dates on them and I requested a no-charge replacement of all batteries that do not have an expiration date on the battery label. Name: ____________________________________________________ Title: _____________ Signature: _________________________________________________________________ Institution: _________________________________________________________________ City: ____________________________ State: ________________________________ Telephone #: _____________________ Email: ________________________________ Please Complete Form, Print, Sign and Fax-Back this Form to 1-781-891-4806 or Complete Form, Print, Sign and Email this signed PDF form to

SSBR@novabio.com


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