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Class 2 Device Recall Microtainer Safety Flow Lancets |
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Date Initiated by Firm |
September 26, 2007 |
Date Posted |
October 18, 2007 |
Recall Status1 |
Terminated 3 on January 15, 2008 |
Recall Number |
Z-0045-2008 |
Recall Event ID |
44940 |
Product Classification |
Lancets - Product Code F MK
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Product |
Microtainer Safety flow Lancets; Yellow Sterile Use once and discard; 2.2mm Blade Length; 1.0mm blade width; Becton Dickinson Vacutainer System; Becton Dickinson and Company; Franklin Lakes, NJ 07417 |
Code Information |
Catalog number 365759; Lot nuimbers: 2340323, 3017522, 3049342, 3069725, 3136072, 3149410, 3220675, 3213535, 2319394. |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact |
201-847-7186
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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.
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FDA Determined Cause 2 |
Process design |
Action |
Recall communication issued on or about 9/28/2007. |
Quantity in Commerce |
1,978,000 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. |
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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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