Class 2 Device Recall BD Visitec

• Date Initiated by Firm: September 16, 2004
• Date Posted: August 14, 2004
• Recall Status: Terminated on February 17, 2005
• Recall Number: Z-1344-04
• Recall Event ID: 29568
• 510(K)Number: K820618
• Product Classification: Knife, Ophthalmic - Product Code HNN
• Product: BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240
• Code Information: Lot Numbers: 3182770, 3231212, 3234243, 3238890, 3274064, 3281592, 3318026, 3325843, 3330607, 3344597, 3344633, 4012982, 4033079, 4049076, 4069650, 4084089, 4084102, 4106845, 4125046, 4141947, 4147817
• FEI Number: 1211998
• Recalling Firm/ Manufacturer: BD Opthalmic Systems; 411 Waverley Oaks Rd Ste 2229; Bldg. 2; Waltham MA 02452-8448
• For Additional Information Contact: David Cromwick; 781-906-7916
• Manufacturer Reason for Recall: Blade may become detached from the handle
• FDA Determined Cause: Other
• Action: BD Medical initiated recall by telephone the week of 7/19/04 to direct accounts advising of the recall action, requesting return and providing replacement product.
• Quantity in Commerce: 6945 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.

• 510(K) Database: 510(K)s with Product Code = HNN