Class 2 Device Recall BD Beaver

• Date Initiated by Firm: December 26, 2006
• Date Posted: February 08, 2007
• Recall Status: Terminated on March 07, 2016
• Recall Number: Z-0404-2007
• Recall Event ID: 37057
• Product Classification: manual surgical instrument - 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 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: 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: 249,000 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.