Class 2 Device Recall Introducer catheter

• Date Initiated by Firm: January 10, 2005
• Date Posted: March 18, 2005
• Recall Status: Terminated on April 12, 2005
• Recall Number: Z-0628-05
• Recall Event ID: 30864
• 510(K)Number: K941428
• Product Classification: Introducer, Catheter - Product Code DYB
• Product: BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray
• Code Information: Ref. No. 680124, Lot No''s. 406462 and 311197
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy; 9450 S State St; Sandy UT 84070
• For Additional Information Contact: 801-565-2300
• Manufacturer Reason for Recall: Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
• FDA Determined Cause: Other
• Action: Customers were contacted by telephone and by letters dated 01/10/05.
• Quantity in Commerce: 15 units
• Distribution: Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.
• 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 = DYB and Original Applicant = OHMEDA MEDICAL