Class 2 Device Recall BD Ophthalmic

• Date Initiated by Firm: September 15, 2008
• Date Posted: October 03, 2008
• Recall Status: Terminated on February 29, 2012
• Recall Number: Z-0022-2009
• Recall Event ID: 49436
• Product Classification: Ophthalmic Cannula - Product Code HMX
• Product: BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
• Code Information: Lot Number: 8018591
• Recalling Firm/ Manufacturer: Becton Dickinson and Company; 411 Waverley Oaks Rd Ste 2229; Waltham MA 02452-8448
• For Additional Information Contact: SAME; 781-906-7950
• Manufacturer Reason for Recall: Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.
• FDA Determined Cause: Employee error
• Action: BD contacted accounts by telephone on 9/15/08 requesting users to discard units and complete the response form. Contact Becton Dickinson and Co. at 1-781-906-7950 for assistance.
• Quantity in Commerce: 1485 units
• Distribution: AZ, CA, CO, IL, OH, FL, PA , TN, TX,and VA Foreign: Australia 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.