Detailed Result for Z-2196-2010

CFRES ID: 92761
Device Name: N/A
Product RES Number: Z-2196-2010
Event Date Initiated: 2010-06-23
Event Date Posted: 2010-08-10
Event Date Created: N/A
Event Date Terminated: 2010-08-11
Recall Status: Terminated
Res Event Number: 56157
Product Code: NMF
K Numbers: ["K011832"]
PMA Numbers: N/A
Product Description: ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
Code Info: Lot: 869509, 878402, 878439, 879762, 879990, 880274.
Recalling Firm: Ascent Healthcare Solutions, Inc.
Firm FEI Number: N/A
Adress 1: 5307 Great Oak Drive
Adress 2: N/A
City: Lakeland
State: FL
Postal Code: 33815-3113
Additional Contact Info: Moira Barton-Varty 863-683-8680
Reason for Recall: 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.
Root Cause Description: Reprocessing Controls
Other Submission Description: N/A
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.
Product Quantity: 175 devices
Distribution Pattern: Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.
Medical Speciality Description: N/A
Regulation Number: N/A
Event Date Posted: 2010-08-10
Device Class: N/A
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"]}
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