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.
This recall has been terminated (originally issued December 16, 2008).
- Recall Initiated
- September 8, 2008
- Posted
- December 16, 2008
- Terminated
- January 29, 2016
- Recall Number
- Z-0504-2009
- Quantity
- 664 pieces
- Official Source
- View on FDA website ↗
Reason for Recall
No 510k approved
Distribution
Nationwide Distribution --- including states of AR, CA, CO, CT, IL,IN, OK. OH, MA, MS, MD, NC, and NY.
Lot / Code Info
All lot numbers
Root Cause
Other
Action Taken
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.