| Class 2 Device Recall BD Beaver | |
Date Initiated by Firm | December 26, 2006 |
Date Posted | February 08, 2007 |
Recall Status1 |
Terminated 3 on March 07, 2016 |
Recall Number | Z-0407-2007 |
Recall Event ID |
37057 |
Product Classification |
manual surgical instrument - Product Code HNN
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Product | BD Beaver Mini-Blade, Blade Mini Sharp All Around S/SU, Catalog Number: 376900 |
Code Information |
Lot Numbers: 6137932, 6142435, 6158382, 6180374, 6187250, 6192282, 6194468, 6198656, 6209256, 6220182, 6223296, 6234908, 6240871, 6243911, 6248083, 6261021, 6271650, 6276887 6283485* 6289455* 6304844* 6317038* 6333608* 6338256* 6342185* |
Recalling Firm/ Manufacturer |
Becton Dickinson and Company 411 Waverley Oaks Rd Ste 2229 Waltham MA 02452-8448
|
For Additional Information Contact | David Cromwick 781-906-7950 |
Manufacturer Reason for Recall | Product sterility may be compromised due to incomplete package seal |
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 | 136,032 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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