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CFRES ID:
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92761 |
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Device Name:
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N/A |
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Product RES Number:
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Z-2196-2010 |
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Event Date Initiated:
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2010-06-23 |
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Event Date Posted:
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2010-08-10 |
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Event Date Created:
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N/A |
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Event Date Terminated:
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2010-08-11 |
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Recall Status:
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Terminated |
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Res Event Number:
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56157 |
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Product Code:
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NMF |
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K Numbers:
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["K011832"] |
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PMA Numbers:
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N/A |
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Product Description:
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ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165. |
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Code Info:
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Lot: 869509, 878402, 878439, 879762, 879990, 880274. |
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Recalling Firm:
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Ascent Healthcare Solutions, Inc. |
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Firm FEI Number:
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N/A |
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Adress 1:
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5307 Great Oak Drive |
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Adress 2:
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N/A |
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City:
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Lakeland |
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State:
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FL |
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Postal Code:
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33815-3113 |
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Additional Contact Info:
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Moira Barton-Varty
863-683-8680 |
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Reason for Recall:
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The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated. |
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Root Cause Description:
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Reprocessing Controls |
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Other Submission Description:
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N/A |
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Action:
|
Ascent sent an urgent medical device voluntary recall notification Letter and Response Form to each consignee on June 25, 2010. Consignees were requested to immediately examine their inventory of Ascent Reprocessed FemoStop devices with lot numbers located on an attached list; remove and quarantine all affected devices; complete the attached Recall Effectiveness Check Form; ship all affected product back to Ascent using the address indicated in the letter, and fax a completed Recall Effectiveness Check Form to 480-763-5350. |
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Product Quantity:
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175 devices |
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Distribution Pattern:
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Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA. |
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Medical Speciality Description:
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N/A |
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Regulation Number:
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N/A |
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Event Date Posted:
|
2010-08-10 |
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Device Class:
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N/A |
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Open FDA:
|
{"k_number"=>["K011832", "K012574", "K120204"], "device_name"=>"Clamp, Vascular, Reprocessed", "medical_specialty_description"=>"Cardiovascular", "regulation_number"=>"870.4450", "device_class"=>"2", "registration_number"=>["2183744"], "fei_number"=>["2183744"]} |