ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
FDA device recall Z-2196-2010 · posted 2010-08-10 · Terminated
Recall details
- Recalling firm
- Ascent Healthcare Solutions, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NMF
- Quantity affected
- 175 devices
- Distribution
- Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.
- Date initiated
- 2010-06-23
- Date posted
- 2010-08-10
- Date terminated
- 2010-08-11
- Location
- Lakeland, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE (K011832) | Vanguard Medical Concepts, Inc. | 2001-12-21 |