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Class 2 Device Recall BD Beaver |
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Date Initiated by Firm |
December 26, 2006 |
Date Posted |
February 08, 2007 |
Recall Status1 |
Terminated 3 on March 07, 2016 |
Recall Number |
Z-0405-2007 |
Recall Event ID |
37057 |
Product Classification |
manual surgical instrument - Product Code HNN
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Product |
BD Beaver¿ Mini-Blade, Blade Mini Pointed Tip S/SU, Catalog Number: 376500 |
Code Information |
Lot Numbers: 6136891, 6158973, 6164128, 6167321, 6172845, 6179889, 6186623, 6198098, 6213333, 6248635, 6251884 6265045* 6275006* 6297349* 6321708* |
Recalling Firm/ Manufacturer |
Becton Dickinson and Company 411 Waverley Oaks Rd Ste 2229 Waltham MA 02452-8448
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For Additional Information Contact |
David Cromwick 781-906-7950
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Manufacturer Reason for Recall |
Product sterility may be compromised due to incomplete package seal
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FDA Determined Cause 2 |
Other |
Action |
On 12/26/2006 BD Medical, Ophthalmic Systems mailed a recall notification letter to US Distributors and US OEM''s. Customers are instructed to return any affected products to BD for a replacement.
On 1/10/07, the firm expanded the recall to additional lots. Those lots are noted with an asterisk. |
Quantity in Commerce |
47,304 units |
Distribution |
Worldwide, including USA, Asia, Australia, Canada, Mexico, Taiwan, Singapore, Korea, and Japan. |
Total Product Life Cycle |
TPLC Device Report
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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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