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U.S. Department of Health and Human Services

Class 2 Device Recall BD Beaver

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 Class 2 Recall
BD Beaver
see related information
Date Posted February 08, 2007
Recall Status1 Open
Recall Number Z-0404-2007
Recall Event ID 37057
Product Classification Knife, Ophthalmic - Product Code HNN
Product BD Beaver® Mini-Blade, Blade Mini RND Tip Sharp One Side, Catalog Number: 376400
Code Information Lot Numbers: 6138940, 6146142, 6156739, 6166196, 6167300, 6172592, 6177437, 6186449, 6191356, 6193323, 6195540, 6200787, 6205116, 6212332, 6215951, 6222023, 6228063, 6233806, 6241023, 6255156, 6262012, 6269131, 6278501 6296135* 6300614* 6312509* 6331680* 6338257* 6346693*
Recalling Firm/
Manufacturer
Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham, Massachusetts 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
PRODUCTION CONTROLS: Process Control
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 249,000 units
Distribution Worldwide, including USA, Asia, Australia, Canada, Mexico, Taiwan, Singapore, Korea, and Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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