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U.S. Department of Health and Human Services

Class 2 Device Recall Truform Therapeutic Classic Medical Style Compression Pantyhose

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  Class 2 Device Recall Truform Therapeutic Classic Medical Style Compression Pantyhose see related information
Date Initiated by Firm October 07, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on March 05, 2013
Recall Number Z-0392-2012
Recall Event ID 60371
Product Classification Stocking, medical support (for general medical purposes) - Product Code FQL
Product Truform Therapeutic Classic Medical Style Compression Pantyhose 20-30 mmHG, A Div of SAI, Cincinnati, OH 45209

Product Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose veins and swelling.
Code Information Lot Num 27806 Item 1756BL-T UPC 048503275655 Lot Num 27859 Item 1757BG-XT UPC 048503175764 Lot Num 27870 Item 1756-T UPC 048503175658 Lot Num 27883 Item 1756BL-XT UPC 048503275662 Lot Num 27892 Item 1756-T UPC 048503175658 Lot Num 27924 Item 1756-XT UPC 048503175665 Lot Num 27929 Item 1756-T UPC 048503175658 Lot Num 27983 Item 1757BG-T UPC 048503175757 Lot Num 27983 Item 1757BG-XT UPC 048503175764 Lot Num 27983 Item 1756-M UPC 048503175634 Lot Num 27983 Item 1756-T UPC 048503175658 Lot Num 27983 Item 1757BG-M UPC 048503175733 Lot Num 27990 Item 1756BL-XT UPC 048503275662 Lot Num 28038 Item 1756BL-T UPC 048503275655 Lot Num 28038 Item 1757BL-P UPC 048503275723 Lot Num 28092 Item 1756BL-T UPC 048503275655 Lot Num 28092 Item 1757BL-M UPC 048503275730 Lot Num 28092 Item 1757BL-P UPC 048503275723 Lot Num 28931 Item 1757WH-T UPC 048503475758 Lot Num 28943 Item 1757BG-XT UPC 048503175764 Lot Num 28963 Item 1756BL-T UPC 048503275655 Lot Num 28966 Item 1757BL-XT UPC 048503275761 Lot Num 28983 Item 1756-XT UPC 048503175665 Lot Num 28993 Item 1756BL-P UPC 048503275624 Lot Num 28993 Item 1756BL-M UPC 048503275631 Lot Num 28999 Item 1756-T UPC 048503175658 Lot Num 29050 Item 1758BG-XT UPC 048503175863 Lot Num 29208 Item 1756BL-T UPC 048503275655 Lot Num 29230 Item 1756-P UPC 048503175627 Lot Num 29360 Item 1758BG-T UPC 048503175856 Lot Num 29687 Item 1756-M UPC 048503175634 Lot Num 29705 Item 1756-T UPC 048503175658 Lot Num 29708 Item 1756BL-T UPC 048503275655 Lot Num 29827 Item 1756BL-XT UPC 048503275662 Lot Num 29838 Item 1756-M UPC 048503175634 Lot Num 29838 Item 1756-T UPC 048503175658 Lot Num 29838 Item 1757BG-M UPC 048503175733 Lot Num 29845 Item 1758BG-T UPC 048503175856 Lot Num 29883 Item 1757BG-XT UPC 048503175764 Lot Num 29883 Item 1756-M UPC 048503175634 Lot Num 29883 Item 1757BG-M UPC 048503175733 Lot Num 29890 Item 1756BL-P UPC 048503275624 Lot Num 29890 Item 1757BL-M UPC 048503275730 Lot Num 30040 Item 1757BG-T UPC 048503175757 Lot Num 30147 Item 1757BL-M UPC 048503275730 Lot Num 30157 Item 1757BG-XT UPC 048503175764 Lot Num 30157 Item 1758BG-XT UPC 048503175863 Lot Num 30168 Item 1757BL-XT UPC 048503275761 Lot Num 30169 Item 1756BL-T UPC 048503275655 Lot Num 30169 Item 1757BL-M UPC 048503275730 Lot Num 30169 Item 1757BL-XT UPC 048503275761 Lot Num 30169 Item 1757BL-XT UPC 048503275761 Lot Num 30169 Item 1756BL-M UPC 048503275631 Lot Num 30174 Item 1757BG-T UPC 048503175757 Lot Num 30174 Item 1756-XT UPC 048503175665 Lot Num 30174 Item 1756-XT UPC 048503175665 Lot Num 30175 Item 1756BL-M UPC 048503275631 Lot Num 30182 Item 1758BG-T UPC 048503175856 Lot Num 30188 Item 1757BG-M UPC 048503175733 Lot Num 30204 Item 1756-T UPC 048503175658 Lot Num 30253 Item 1756BL-T UPC 048503275655 Lot Num 30253 Item 1756BL-XT UPC 048503275662 Lot Num 30253 Item 1757BL-P UPC 048503275723 Lot Num 30292 Item 1756-T UPC 048503175658 Lot Num 30312 Item 1756-T UPC 048503175658 Lot Num 30326 Item 1756BL-XT UPC 048503275662 Lot Num 30336 Item 1756-T UPC 048503175658 Lot Num 30342 Item 1756BL-T UPC 048503275655 Lot Num 30360 Item 1757BG-T UPC 048503175757 Lot Num 30360 Item 1757BG-XT UPC 048503175764 Lot Num 30360 Item 1756-T UPC 048503175658 Lot Num 30360 Item 1756-XT UPC 048503175665 Lot Num 30380 Item 1756BL-P UPC 048503275624 Lot Num 30388 Item 1757BG-P UPC 048503175726 Lot Num 30449 Item 1756BL-XT UPC 048503275662 Lot Num 30452 Item 1757BG-XT UPC 048503175764 Lot Num 30526 Item 1758BG-XT UPC 048503175863 Lot Num 30560 Item 1756-T UPC 048503175658 Lot Num 30560 Item 1756-XT UPC 048503175665 Lot Num 30560 Item 1757BG-P UPC 048503175726 Lot Num 30591 Item 1756BL-T UPC 048503275655 Lot Num 30591 Item 1756BL-XT UPC 048503275662 Lot Num 30680 Item 1756-XT UPC 048503175665 Lot Num 30697 Item 1757BL-XT UPC 048503275761 Lot Num 30747 Item 1757BG-M UPC 048503175733 Lot Num 30826 Item 1756BL-P UPC 048503275624 Lot Num 30826 Item 1756BL-T UPC 048503275655 Lot Num 30835 Item 1757BG-T UPC 048503175757 Lot Num 30835 Item 1756-T UPC 048503175658 Lot Num 30854 Item 1758BG-XT UPC 048503175863 Lot Num 30854 Item 1756-XT UPC 048503175665 Lot Num 30932 Item 1756-M UPC 048503175634 Lot Num 30932 Item 1757BG-M UPC 048503175733 Lot Num 30982 Item 1756BL-T UPC 048503275655 Lot Num 30983 Item 1756-T UPC 048503175658 Lot Num 31011 Item 1756-P UPC 048503175627 Lot Num 31062 Item 1756BL-T UPC 048503275655 Lot Num 31124 Item 1756BL-XT UPC 048503275662 Lot Num 31125 Item 1756-XT UPC 048503175665 Lot Num 31184 Item 1757BG-XT UPC 048503175764 Lot Num 31229 Item 1756-P UPC 048503175627 Lot Num 31313 Item 1757BG-T UPC 048503175757 Lot Num 31336 Item 1757BG-XT UPC 048503175764 Lot Num 31336 Item 1756-P UPC 048503175627 Lot Num 31336 Item 1756-XT UPC 048503175665 Lot Num 31336 Item 1757BG-P UPC 048503175726 Lot Num 31336 Item 1757BG-T UPC 048503175757 Lot Num 31338 Item 1756-T UPC 048503175658 Lot Num 31370 Item 1758BG-M UPC 048503175832 Lot Num 31387 Item 1756BL-T UPC 048503275655 Lot Num 31387 Item 1756BL-M UPC 048503275631 Lot Num 31406 Item 1756-XT UPC 048503175665 Lot Num 31435 Item 1756BL-P UPC 048503275624 Lot Num 31435 Item 1756BL-T UPC 048503275655 Lot Num 31435 Item 1757BL-T UPC 048503275754 Lot Num 31445 Item 1756BL-XT UPC 048503275662 Lot Num 31487 Item 1756-T UPC 048503175658 Lot Num 31487 Item 1757BG-M UPC 048503175733 Lot Num 31487 Item 1757BG-T UPC 048503175757 Lot Num 31548 Item 1756BL-XT UPC 048503275662 Lot Num 31548 Item 1757BL-P UPC 048503275723 Lot Num 31548 Item 1757BL-T UPC 048503275754 Lot Num 31548 Item 1757BL-XT UPC 048503275761 Lot Num 31599 Item 1756-T UPC 048503175658 Lot Num 31640 Item 1756BL-XT UPC 048503275662 Lot Num 31650 Item 1757BG-XT UPC 048503175764 Lot Num 31650 Item 1756-XT UPC 048503175665 Lot Num 31704 Item 1756-T UPC 048503175658 Lot Num 31722 Item 1757BG-XT UPC 048503175764 Lot Num 31730 Item 1756-XT UPC 048503175665 Lot Num 31743 Item 1756BL-XT UPC 048503275662 Lot Num 31783 Item 1756BL-T UPC 048503275655 Lot Num 31783 Item 1756BL-XT UPC 048503275662 Lot Num 31783 Item 1757BL-XT UPC 048503275761 Lot Num 31783 Item 1758BL-M UPC 048503275839 Lot Num 31848 Item 1756BL-T UPC 048503275655 Lot Num 31854 Item 1756-T UPC 048503175658 Lot Num 31876 Item 1758BG-XT UPC 048503175863 Lot Num 31883 Item 1756-T UPC 048503175658 Lot Num 32078 Item 1757BG-XT UPC 048503175764 Lot Num 32256 Item 1756BL-P UPC 048503275624 Lot Num 32265 Item 1756-T UPC 048503175658 Lot Num 32299 Item 1757BG-T UPC 048503175757 Lot Num 32325 Item 1756-T UPC 048503175658 Lot Num 32325 Item 1756-T UPC 048503175658 Lot Num 32339 Item 1756-T UPC 048503175658 Lot Num 32399 Item 1756-T UPC 048503175658 Lot Num 32464 Item 1756-T UPC 048503175658 Lot Num 32565 Item 1756-M UPC 048503175634 Lot Num 32565 Item 1756-M UPC 048503175634 Lot Num 32620 Item 1757BL-P UPC 048503275723 Lot Num 32620 Item 1757BL-XT UPC 048503275761 Lot Num 32620 Item 1756BL-M UPC 048503275631 Lot Num 32666 Item 1757BG-T UPC 048503175757 Lot Num 32671 Item 1756-T UPC 048503175658 Lot Num 32776 Item 1756-M UPC 048503175634 Lot Num 32776 Item 1757BG-M UPC 048503175733 Lot Num 32840 Item 1758BG-XT UPC 048503175863 Lot Num 32903 Item 1756-M UPC 048503175634 Lot Num 32908 Item 1757BG-T UPC 048503175757 Lot Num 32915 Item 1756BL-T UPC 048503275655 Lot Num 32916 Item 1756BL-M UPC 048503275631 Lot Num 32942 Item 1756-T UPC 048503175658 Lot Num 33060 Item 1756BL-T UPC 048503275655 Lot Num 33071 Item 1756-XT UPC 048503175665 Lot Num 33075 Item 1756BL-XT UPC 048503275662 Lot Num 33084 Item 1758BG-T UPC 048503175856 Lot Num 33180 Item 1757BG-T UPC 048503175757 Lot Num 33187 Item 1756-XT UPC 048503175665 Lot Num 33194 Item 1757BG-XT UPC 048503175764 Lot Num 33249 Item 1756BL-M UPC 048503275631 Lot Num 33317 Item 1756BL-M UPC 048503275631 Lot Num 33321 Item 1756BL-T UPC 048503275655 Lot Num 33388 Item 1756-T UPC 048503175658 Lot Num 33388 Item 1757BG-T UPC 048503175757 Lot Num 33420 Item 1756BL-M UPC 048503275631 Lot Num 33430 Item 1756BL-T UPC 048503275655 Lot Num 33447 Item 1756BL-P UPC 048503275624 Lot Num 33505 Item 1757BG-XT UPC 048503175764 Lot Num 33544 Item 1756-XT UPC 048503175665 Lot Num 33544 Item 1757BG-T UPC 048503175757 Lot Num 33622 Item 1756-T UPC 048503175658 Lot Num 33633 Item 1756-XT UPC 048503175665 Lot Num 33651 Item 1756-M UPC 048503175634 Lot Num 33652 Item 1756BL-T UPC 048503275655 Lot Num 33652 Item 1756BL-XT UPC 048503275662 Lot Num 33682 Item 1756-P UPC 048503175627 Lot Num 33682 Item 1757BG-T UPC 048503175757 Lot Num 33682 Item 1757BG-T UPC 048503175757 Lot Num 33693 Item 1756-T UPC 048503175658 Lot Num 33693 Item 1757BG-M UPC 048503175733 Lot Num 33712 Item 1756-T UPC 048503175658 Lot Num 33742 Item 1756-XT UPC 048503175665 Lot Num 33756 Item 1757BG-XT UPC 048503175764 Lot Num 33758 Item 1756-P UPC 048503175627 Lot Num 33758 Item 1757BG-P UPC 048503175726 Lot Num 33760 Item 1756BL-P UPC 048503275624 Lot Num 33789 Item 1756BL-XT UPC 048503275662 Lot Num 33803 Item 1756-M UPC 048503175634 Lot Num 33852 Item 1756BL-M UPC 048503275631 Lot Num 33899 Item 1756-T UPC 048503175658 Lot Num 33899 Item 1757BG-T UPC 048503175757 Lot Num 33910 Item 1756-M UPC 048503175634 Lot Num 33910 Item 1756-T UPC 048503175658 Lot Num 33910 Item 1756-XT UPC 048503175665 Lot Num 34069 Item 1758BG-M UPC 048503175832 Lot Num 34080 Item 1756BL-XT UPC 048503275662 Lot Num 34090 Item 1756BL-T UPC 048503275655 Lot Num 34090 Item 1756BL-XT UPC 048503275662 Lot Num 34130 Item 1758BG-T UPC 048503175856 Lot Num 34131 Item 1758BG-XT UPC 048503175863 Lot Num 34131 Item 1758BG-XT UPC 048503175863 Lot Num 34149 Item 1756-T UPC 048503175658 Lot Num 34177 Item 1756-M UPC 048503175634 Lot Num 34215 Item 1756-P UPC 048503175627 Lot Num 34236 Item 1756-XT UPC 048503175665 Lot Num 34247 Item 1757BG-XT UPC 048503175764 Lot Num 34296 Item 1758BG-T UPC 048503175856 Lot Num 34296 Item 1756-T UPC 048503175658 Lot Num 34331 Item 1756-M UPC 048503175634 Lot Num 34331 Item 1757BG-T UPC 048503175757
Recalling Firm/
Manufacturer		 Surgical Appliance Industries
3960 Rosslyn Dr
Cincinnati OH 45209
For Additional Information Contact Richard J. Stautberg
513-271-4594 Ext. 282
Manufacturer Reason
for Recall		 During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s
FDA Determined
Cause 2		 Employee error
Action The firm, Surgical Appliance Industries sent an URGENT: MEDICAL DEVICE RECALL letters dated November 7, 2011 to all affected customers. The letter described the products, problem and actions to be taken. Customers were instructed to immediately examine their inventory and quarantine all product(s) subject to recall for return and exchange. In addition, the letter states that if the product was further distributed to contact their customers and notify them of the recall. Customers were asked to complete and return the enclosed Recall Response Form. For any questions contact Quality Systems Manager, at 513-271-4594 ext. 282.
Quantity in Commerce 11819 pairs
Distribution Worldwide Distribution - USA (nationwide) and the countries of: Australia, Canada, Colombia, Hong Kong, Peru, Singapore, Spain, and Venezuela.
Total Product Life Cycle TPLC 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.
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