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U.S. Department of Health and Human Services

Class 2 Device Recall BD Latitude

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  Class 2 Device Recall BD Latitude see related information
Date Initiated by Firm July 23, 2003
Date Posted September 11, 2003
Recall Status1 Terminated 3 on December 02, 2004
Recall Number Z-1221-03
Recall Event ID 26927
510(K)Number K022580  K022581  
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA 02454, Distributed by Becton Dickinson Canada, Inc., Oakville, ON.
Code Information Catalog # 322002 (fifty count packaging) Lot Number: 2064256.  Catalog # 322003 (one hundred count packaging) Lot Numbers: 2064256, 2064273, 2071280.
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Drive
Franklin Lakes NJ 07417
For Additional Information Contact Wayne Kazarian
201-847-6087
Manufacturer Reason
for Recall		 Test Strips may not be meeting specifications at the lower range of glucose values.
FDA Determined
Cause 2		 Other
Action On July 23, Becton Dickinson Canada sent out a recall notification to their Canadian customers to recall the product and return to BD Canada.
Quantity in Commerce 754800 strips
Distribution Product was distributed to the Becton Dickinson Canada, Inc.,
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 & CO.
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