FDA · Medical device recall

Truform Therapeutic Classic Medical Style Compression Stockings 20-30… and 1 more product

Jan. 11, 2012

Date posted by the FDA: Jan. 11, 2012
Status: Terminated
Filed by: Surgical Appliance Industries
Reason: 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
Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of: Australia, Canada, Colombia, Hong Kong, Peru, Singapore, Spain, and Venezuela.

2 products in this recall

Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG…

Product: Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG, Truform Therapeutic Classic Medical Style Compression Stockings 30-40 mmHG, A Div of SAI, Cincinnati, OH 45209 Product Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose veins and swelling.
Quantity: 351896 pairs
Codes and lots: Lot Num 21201 Item 8865S-M UPC 048503386535 Lot Num 27541 Item 8866-L UPC 048503886653 Lot Num 27542 Item 8865-L UPC 048503886554 Lot Num 27610 Item 8866-L UPC 048503886653 Lot Num 27671 Item 0845BL-XL UPC 048503284565 Lot Num 27702 Item 8865-M UPC 048503886530 Lot Num 27723 Item 8865-L UPC 048503886554 Lot Num 27728 Item 8865-XL UPC 048503886561 Lot Num 27753 Item 8865-L UPC 048503886554 Lot Num 27767 Item 8865-XL UPC 048503886561 Lot Num 27795 Item 8845-XL UPC 048503884567 Lot Num 27803 Item 8865-L UPC 048503886554 Lot Num 27859 Item 8865-L UPC 048503886554 Lot Num 27860 Item 8865-M UPC 048503886530 Lot Num 27869 Item 8865BL-L UPC 048503826550 Lot Num 27875 Item 8865-M UPC 048503886530 Lot Num 27892 Item 0865-3L UPC 048503086589 Lot Num 27901 Item 8864BG-XL UPC 048503886462 Lot Num 27910 Item 8845BL-XL UPC 048503824563 Lot Num 27919 Item 8865BL-M UPC 048503826536 Lot Num 27922 Item 8845-XL UPC 048503884567 Lot Num 27934 Item 0865-3L UPC 048503086589 Lot Num 27937 Item 8848BG-XL UPC 048503884864 Lot Num 27938 Item 0864BG-XL UPC 048503086466 Lot Num 27938 Item 0864BG-XL UPC 048503086466 Lot Num 27938 Item 8868BG-L UPC 048503886851 Lot Num 27952 Item 8865-L UPC 048503886554 Lot Num 27960 Item 8867BG-L UPC 048503886752 Lot Num 27969 Item 8865BL-L UPC 048503826550 Lot Num 27970 Item 0865-3L UPC 048503086589 Lot Num 27970 Item 8868BG-M UPC 048503886837 Lot Num 27970 Item 8865-3L UPC 048503886585 Lot Num 27976 Item 8868BL-L UPC 048503826857 Lot Num 27984 Item 0845-2L UPC 048503084578 Lot Num 27984 Item 8845-2L UPC 048503884574 Lot Num 27986 Item 0865-3L UPC 048503086589 Lot Num 27989 Item 0865BL-2L UPC 048503286576 Lot Num 27998 Item 8868BG-L UPC 048503886851 Lot Num 28017 Item 8848BG-XL UPC 048503884864 Lot Num 28023 Item 8865-M UPC 048503886530 Lot Num 28034 Item 8865-M UPC 048503886530 Lot Num 28041 Item 8865BL-M UPC 048503826536 Lot Num 28041 Item 8865BL-XL UPC 048503826567 Lot Num 28041 Item 8865-L UPC 048503886554 Lot Num 28044 Item 8848BL-XL UPC 048503824860 Lot Num 28050 Item 8848BG-XL UPC 048503884864 Lot Num 28075 Item 8865-L UPC 048503886554 Lot Num 28079 Item 8865-M UPC 048503886530 Lot Num 28079 Item 8865-M UPC 048503886530 Lot Num 28821 Item 8845-L UPC 048503884550 Lot Num 28821 Item 8845-XL UPC 048503884567 Lot Num 28825 Item 0845-XL UPC 048503084561 Lot Num 28849 Item 8865-M UPC 048503886530 Lot Num 28869 Item 8865-M UPC 048503886530 Lot Num 28869 Item 8865-M UPC 048503886530 Lot Num 28872 Item 8866-XL UPC 048503886660 Lot Num 28913 Item 0845-XL UPC 048503084561 Lot Num 28926 Item 8865-M UPC 048503886530 Lot Num 28926 Item 8865-M UPC 048503886530 Lot Num 28930 Item 8865-M UPC 048503886530 Lot Num 28934 Item 8845-XL UPC 048503884567 Lot Num 28939 Item 8865-L UPC 048503886554 Lot Num 28940 Item 8865-M UPC 048503886530 Lot Num 28947 Item 8866-M UPC 048503886639 Lot Num 28948 Item 8848BG-XL UPC 048503884864 Lot Num 28985 Item 8865-M UPC 048503886530 Lot Num 28992 Item 0868BL-M UPC 048503286835 Lot Num 29004 Item 8866-L UPC 048503886653…
Recall started: Oct. 7, 2011
Device type: Stocking, Medical Support (For General Medical Purposes)
Root cause (FDA): Employee error
What the company told customers: 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.
Recall number: Z-0391-2012

Truform Therapeutic Classic Medical Style Compression Pantyhose 20-30 mmHG…

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.
Quantity: 11819 pairs
Codes and lots: 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…
Recall started: Oct. 7, 2011
Device type: Stocking, Medical Support (For General Medical Purposes)
Root cause (FDA): Employee error
What the company told customers: 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.
Recall number: Z-0392-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0391-2012, Z-0392-2012. The agency record governs; check it and the company before acting.

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