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U.S. Department of Health and Human Services

Class 2 Device Recall Singleuse sterile puncture attachment UA1256U

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  Class 2 Device Recall Singleuse sterile puncture attachment UA1256U see related information
Date Initiated by Firm September 08, 2008
Date Posted December 16, 2008
Recall Status1 Terminated 3 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 2		 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.
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