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Terminated

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.

FDA Recall Z-0504-2009 · Posted 2008-12-16

Recalling FirmBk Medical
Recall StatusTerminated
Date Initiated2008-09-08
Date Terminated2016-01-29
Product Quantity664 pieces

Reason for Recall

No 510k approved

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution --- including states of AR, CA, CO, CT, IL,IN, OK. OH, MA, MS, MD, NC, and NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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