Z-2196-2010

ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165

Name: Z-2196-2010 ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165
Creator: Ascent Healthcare Solutions, Inc.
Published: 2010-06-23
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2010-06-23 / Terminated

FDA source

Ascent Healthcare Solutions, Inc. began a recall of ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165 on 2010-06-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2196-2010
Status: Terminated
Initiated: 2010-06-23
Posted: 2010-08-10
Terminated: 2010-08-11
Recalling firm: Stryker Sustainability Solutions
Product: ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
Product code: NMF Clamp, Vascular, Reprocessed
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.
FDA 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 in commerce: 175 devices
Distribution: Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.
Product codes and lots: Lot: 869509, 878402, 878439, 879762, 879990, 880274.

Product code NMF

K011832Class IIVanguard Reprocessed Femoral Compression DeviceVanguard Medical Concepts, Inc. / cleared 2001-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)