Class 2 Device Recall Singleuse sterile puncture attachment UA1256U

• Date Initiated by Firm: September 08, 2008
• Date Posted: December 16, 2008
• Recall Status: Terminated on January 29, 2016
• Recall Number: Z-0504-2009
• Recall Event ID: 50157
• Product: Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.
• Code Information: All lot numbers
• Recalling Firm/ Manufacturer: Bk Medical; Mileparken 34; Iierlev Denmark
• Manufacturer Reason for Recall: No 510k approved
• FDA Determined Cause: Other
• Action: BK Medical notified accounts via a Recall Notice letter dated 9/03/08 to inform customers of the unapproved status and to remove the device from use and it will be replaced with B-K Medical's reusable metal guide UA1256. Customers were to fill out the attached "Reply Form" and return it via fax or the postage paid envelope. Any questions should be directed to B-K Medical Systems, Inc. at 1-800-876-7226.
• Quantity in Commerce: 664 pieces
• Distribution: Nationwide Distribution --- including states of AR, CA, CO, CT, IL,IN, OK. OH, MA, MS, MD, NC, and NY.

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.