ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
FDA Recall Z-2196-2010 · Posted 2010-08-10
Recalling FirmAscent Healthcare Solutions, Inc.
Recall StatusTerminated
Product CodeNMF
Date Initiated2010-06-23
Date Terminated2010-08-11
Product Quantity175 devices
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.
Firm 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.
Root Cause
Reprocessing Controls
Distribution Pattern
Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.