Recall Z-2196-2010 ยท NMF Clamp, Vascular, Reprocessed
Ascent Healthcare Solutions, Inc.
ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
| Date | Aug 10, 2010 (initiated Jun 23, 2010) |
| Status | Terminated |
| Reason | 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 | Reprocessing Controls |
| 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. |
| Quantity | 175 devices |
| Distribution | Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011832 | VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE Vanguard Medical Concepts, Inc., Dec 21, 2001 |