Class 3 Device Recall Visitec

• Date Initiated by Firm: March 02, 2007
• Date Posted: March 29, 2007
• Recall Status: Terminated on March 05, 2008
• Recall Number: Z-0672-2007
• Recall Event ID: 37533
• Product Classification: cataract surgical instrument - Product Code KYG
• Product: BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618
• Code Information: Lot Number: 6181868
• FEI Number: 1211998
• 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: Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)
• FDA Determined Cause: Other
• Action: BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.
• Quantity in Commerce: 1500 units
• Distribution: Nationwide.
• 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.