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U.S. Department of Health and Human Services

Class 2 Device Recall Microtainer Safety Flow Lancets

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  Class 2 Device Recall Microtainer Safety Flow Lancets see related information
Date Initiated by Firm September 26, 2007
Date Posted October 18, 2007
Recall Status1 Terminated 3 on January 15, 2008
Recall Number Z-0046-2008
Recall Event ID 44940
Product Classification Lancets - Product Code F MK
Product Microtainer Safety Flow Lancets; Blue
Sterile Use once and Discard;
1.9mm Blade Length;
1.0 mm Blade Width;
Becton Dickinson Vacutainer Systems
Becton dickinson and COmpany;
Franklin Lakes, NJ 07417
Code Information Catalog number 366357; Lot numbers: 2228742; 3022532; 3037536; 3055877; 3062548; 3079392; 3086096; 3135003; 3142723; 3199645; 3225646; 3240751; 3248047; 3268651; 2323030; 2330450.
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
201-847-7186
Manufacturer Reason
for Recall
Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.
FDA Determined
Cause 2
Process design
Action Recall communication issued on or about 9/28/2007.
Quantity in Commerce 4,349,000 units
Distribution Product distributed worldwide to Australia, Brazil, Canada, China, Colombia, Guatemala, Hong Kong, India, Indonesia, Mexico, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Thailand, and United States.

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.
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