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U.S. Department of Health and Human Services

Class 2 Device Recall FemoStop Reprocessed Femoral Compression Device

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 Class 2 Device Recall FemoStop Reprocessed Femoral Compression Devicesee related information
Date Initiated by FirmJune 23, 2010
Date PostedAugust 10, 2010
Recall Status1 Terminated 3 on August 11, 2010
Recall NumberZ-2196-2010
Recall Event ID 56157
510(K)NumberK011832 
Product Classification Clamp, vascular, reprocessed. - Product Code NMF
ProductASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
Code Information Lot: 869509, 878402, 878439, 879762, 879990, 880274. 
FEI Number 1000132435
Recalling Firm/
Manufacturer		 Ascent Healthcare Solutions, Inc.
5307 Great Oak Drive
Lakeland FL 33815-3113
For Additional Information ContactMoira Barton-Varty
863-683-8680
Manufacturer 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 Determined
Cause 2		Reprocessing Controls
ActionAscent 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 Commerce175 devices
DistributionDevices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NMF
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