Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
This recall has been terminated (originally issued July 11, 2011).
- Company
- Bard Access Systems
- Recall Initiated
- June 21, 2011
- Posted
- July 11, 2011
- Terminated
- July 11, 2012
- Recall Number
- Z-2782-2011
- Quantity
- 86 units
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.