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U.S. Department of Health and Human Services

Class 2 Device Recall Thigh Garment

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 Class 2 Device Recall Thigh Garmentsee related information
Date Initiated by FirmMarch 11, 2008
Date PostedSeptember 19, 2008
Recall Status1 Terminated 3 on June 29, 2012
Recall NumberZ-1676-2008
Recall Event ID 47343
510(K)NumberK012403 
Product Classification Compression garment - Product Code JOW
ProductKendall Thigh Garment - Reprocessed Sterile device -- Compressible limb sleeve.
Code Information Catalog No 9530, Lot No 147056
Recalling Firm/
Manufacturer		 Ascent Healthcare Solutions, Inc.
5307 Great Oak Drive
Lakeland FL 33815-3113
For Additional Information Contact
800-887-2337 Ext. 203
Manufacturer Reason
for Recall		Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
FDA Determined
Cause 2		Process control
ActionA recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.
Quantity in Commerce250 of 250
DistributionClass II Recall - Nationwide Distribution.
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 = JOW
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