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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJanuary 05, 2006
Date PostedFebruary 25, 2006
Recall Status1 Terminated 3 on September 05, 2006
Recall NumberZ-0560-06
Recall Event ID 34292
510(K)NumberK041478 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
ProductBD Logic -- Blood Glucose Monitor.
Code Information All units under the following Catalog Number:  322051(48); 322029; 322068; 322069. 
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactDavid Pieratos
201-847-4548
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		Other
ActionRecall 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 Commerce840,808 units
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = NBW
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