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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 Lancetssee related information
Date Initiated by FirmSeptember 26, 2007
Date PostedOctober 18, 2007
Recall Status1 Terminated 3 on January 15, 2008
Recall NumberZ-0044-2008
Recall Event ID 44940
Product Classification Lancets - Product Code FMK
ProductMicrotainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Code Information Catalog Number 366356 Lot numbers: 2340296, 2353789, 3007400, 3043001, 3073415, 3100407, 3198493.
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
ActionRecall communication issued on or about 9/28/2007.
Quantity in Commerce1,476,000 units
DistributionProduct distributed worldwide to Australia, Brazil, Canada, China, Colombia, Guatemala, Hong Kong, India, Indonesia, Mexico, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Thailand, and United States.
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.
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