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Class 2 Device Recall Site Rite Vision Ultrasound System, |
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Date Initiated by Firm |
June 21, 2011 |
Date Posted |
July 11, 2011 |
Recall Status1 |
Terminated 3 on July 11, 2012 |
Recall Number |
Z-2782-2011 |
Recall Event ID |
57012 |
510(K)Number |
K100402
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Product Classification |
Ultrasound System - Product Code IYN
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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.
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Code Information |
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. |
Recalling Firm/ Manufacturer |
Bard Access Systems 605 North 5600 West Salt Lake City UT 84116-3738
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For Additional Information Contact |
801-522-5614
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Manufacturer Reason for Recall |
Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = IYN and Original Applicant = BARD ACCESS SYSTEMS, INC.
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