Z-2782-2011

Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound...

Name: Z-2782-2011 Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound...
Creator: Bard Access Systems
Published: 2011-06-21
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2011-06-21 / Terminated / root cause: manufacturing process

FDA source

Bard Access Systems began a recall of Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body on 2011-06-21. The reason FDA records is "Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2782-2011
Status: Terminated
Initiated: 2011-06-21
Posted: 2011-07-11
Terminated: 2012-07-11
Recalling firm: Bard Access Systems, Inc.
Product: Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Bard Access Systems, Inc sent out an "Urgent" Medical Device Recall (User Level)" dated June 2011 to all affected customers The letter included: product name, description of problem and requested the return of units bearing "B50" on the fan. Bard Access Systems, Inc. will replace the incorrect fan with the correct fan. For additional information call 1-724-779-3000.
Quantity in commerce: 86 units
Distribution: Nationwide (USA) distribution including the states of AL, AR, AZ, CA, CO, FL, IA, IN, MD, MI, MO, MS, NC, NJ, NM, NY, OH, PA, RI, SC, TX, UT, VA, VT, and WA.
Product codes and lots: Serial numbers: DYUJA023, DYUJA024, DYUJA025, DYUJA026, DYUJA027, DYUJA028, DYUJA029, DYUJA030, DYUJA031, DYUJA032, DYUJA034, DYUJA036, DYUJA037, DYUJA038, DYUJA039, DYUJA040, DYUKA001, DYUKA002, DYUKA003, DYUKA004, DYUKA005, DYUKA006, DYUKA007, DYUKA008, DYUKA009, DYUKA010, DYUKA011, DYUKA012, DYUKA013, DYUKA014, DYUKA015, DYUKA015, DYUKA017, DYUKA018, DYUKA019, DYUKA020, DYVAA001, DYVAA002, DYVAA003, DYVAA004, DYVAA005, DYVAA006, DYVAA007, DYVAA012, DYVAA013, DYVAA014, DYVAA015, DYVAA016, DYVAA017, DYVAA018, DYVAA019, DYVAA020, DYVAA021, DYVAA022, DYVAA023, DYVAA024, DYVAA025, DYVAA026, DYVAA027, DYVAA028, DYVAA029, DYVAA030, DYVAA031, DYVAA032, DYVAA033, DYVAA036, DYVAA037, DYVAA038, DYVAA039, DYVAA040, DYVBA002, DYVBA003, DYVBA004, DYVBA005, DYVBA006, DYVBA007, DYVBA008, DYVBA009, DYVBA010, DYVBA011, DYVBA012, DYVBA013, DYVBA014, DYVBA015, DYVBA018, DYVBA019, DYVBA020.

Product code IYN

K100402Class IISite-Rite Vision Ultrasound SystemBard Access Systems, Inc. / cleared 2010-03-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)