Z-0504-2009

Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound...

Name: Z-0504-2009 Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound...
Creator: Bk Medical
Published: 2008-09-08
License: https://open.fda.gov/license/

BK Medical ApS / initiated 2008-09-08 / Terminated

FDA source

Bk Medical began a recall of Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound... on 2008-09-08. The reason FDA records is "No 510k approved". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0504-2009
Status: Terminated
Initiated: 2008-09-08
Posted: 2008-12-16
Terminated: 2016-01-29
Recalling firm: BK Medical ApS
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.
Reason for recall: No 510k approved
FDA root 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.
Product codes and lots: All lot numbers

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)