FDA Recall Terminated

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.

Recall: Z-0391-2012 · Initiated October 7, 2011

Recall

Recall Number: Z-0391-2012
Event Number: 60371
Firm: Surgical Appliance Industries
FEI Number: 1511629
Product Code: FQL
Status: Terminated
Root Cause: Employee error
Initiated: October 7, 2011
Posted: January 11, 2012
Terminated: March 5, 2013
Address: 3960 Rosslyn Dr, Cincinnati, OH, 45209

Description

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

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.

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: Australia, Canada, Colombia, Hong Kong, Peru, Singapore, Spain, and Venezuela.

Quantity

351896 pairs