Recall Z-0391-2012 ยท FQL Stocking, Medical Support (For General Medical Purposes)
Surgical Appliance Industries
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.
| Date | Jan 11, 2012 (initiated Oct 7, 2011) |
| Status | Terminated |
| 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 |
| Root cause | 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 |
| Quantity | 351896 pairs |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Australia, Canada, Colombia, Hong Kong, Peru, Singapore, Spain, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.