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| | Class 2 Device Recall Site Rite Vision Ultrasound System, |
| Date Initiated by Firm | June 21, 2011 |
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| Date Posted | July 11, 2011 |
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| Recall Status1 | Terminated 3 on July 11, 2012 |
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| Z-2782-2011 |
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| | Recall Event ID | 57012 |
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| K100402 |
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| Ultrasound System - Product CodeIYN
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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. |
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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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| Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number. |
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| Process control |
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| 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. |
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| 86 units |
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| 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. |
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| 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. |
| 510(K) Database | 510(K)s with Product Code = IYN and Original Applicant = BARD ACCESS SYSTEMS, INC.
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Advertising
F1915 (2012 04)
Dec 30, 2013 For Sale on EBay user ID ArmedForcesSupply 210-273-3394 Www.ArmedForcesSupply.com Like us on Facebook. The SiteRite 5 Ultrasound Systems meets AHRQ recommendations for use of real-time ultrasound guidance for central line placement. Reduction of Complications: Clear vessel visualization reduces risk of inadvertent arterial puncture, hematoma or pneumothorax.
Ibm rational doors 9.6 user manual pdf. Page 1 of 6
BARD MANUFACTURING COMPANY, INC.
QW2S-QW5S Water-to-Air H/P
Engineering Specification Guide
1.0 GENERAL
Furnish and install a self-contained, vertical, floor standing, heat pump to
be manufactured by Bard Manufacturing Company, Inc. The unit shall be
approved and Listed by Intertek ETL Listed (ETL US/C). Unit shall be
factory assembled, pre-charged, pre-wired, tested and ready to operate.
Unit performance shall be AHRI Certified in accordance with ISO Standard
13256-1:1998 “Water to Air and Brine to Air Heat Pumps”, which includes
watt allowance for water pumping. Unit shall include 5 year parts warranty
covering compressor, parts, and heat exchange coils, subject to terms and
conditions of Bard Limited Warranty Agreement.
Unit efficiency shall be specified in terms of EER and COP.
Manufacturers: Capacities shall be as indicated on drawings and units
shall be manufactured by Bard Manufacturing Company, Inc. or prior
approved equal.
2.0 CONSTRUCTION FEATURES
2.1 CABINET
Constructed of 20 gauge pre-painted or vinyl laminated galvanized
steel. Choices available are either two-tone (vinyl) finish with “slate”
front panels and “platinum” cabinet for designer appearance, (gray)
or (beige) painted steel (select one). Vinyl finish is very resistant to
scratching and marring and is easy to clean. Tamper resistant
fasteners are provided for access panels. Unit includes built-in
rollers for each installation into wall sleeve and removal for service,
if necessary. Front panel is hinged and lockable for filter service and
access to primary functional electrical controls.
Bard Site Rite 5 User Manual English
2.2INSULATION
Cabinet is fully insulated with foil covered, high-density fiberglass
insulation with sealed edge treatment and special sound deadening
insulation material in the compressor section. All insulation is
designed to resist mold and mildew growth and facilitate ease of
cleaning.
Bard Site Rite 5 User Manual Pdf
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