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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 05, 2006
Date Posted February 25, 2006
Recall Status1 Terminated 3 on September 05, 2006
Recall Number Z-0562-06
Recall Event ID 34292
510(K)Number K041478  
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product Paradigm Link -- Blood Glucose Monitor.
Code Information All lots under the following Catalog Numbers:  322200; 322201; 322202; 322203; 322204; 322205; 322206; 322207. 
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact David Pieratos
Manufacturer Reason
for Recall
BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
FDA Determined
Cause 2
Action Recall notifications letters began mailing on 1/5/2006 to distributors, retailers, and DME providers. Healthcare professionals and consumers mailings will be during the week of 1/9/2006
Quantity in Commerce 227,240 units
Distribution The firm distributes their blood glucose monitors Nationwide to distributors, retailers, durable Medical Equipment providers, Healthcare Professionals, and consumers. Foreign accounts include locations in Canada and Germany. There is one VA account.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = BECTON DICKINSON