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U.S. Department of Health and Human Services

Class 2 Device Recall BD Beaver

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  Class 2 Device Recall BD Beaver see related information
Date Initiated by Firm December 26, 2006
Date Posted February 08, 2007
Recall Status1 Terminated 3 on March 07, 2016
Recall Number Z-0409-2007
Recall Event ID 37057
Product Classification manual surgical instrument - Product Code HNN
Product BD Beaver¿ Mini-Blade, Mini/Bulk 67, Catalog Number: 374822
Code Information Lot Numbers: 6159386, 6293719
Recalling Firm/
Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham MA 02452-8448
For Additional Information Contact David Cromwick
Manufacturer Reason
for Recall
Product sterility may be compromised due to incomplete package seal
FDA Determined
Cause 2
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 2,000 units
Distribution Worldwide, including USA, Asia, Australia, Canada, Mexico, Taiwan, Singapore, Korea, and Japan.
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.