Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG, Truform Therapeutic Classic Medical Style Co

FDA device recall Z-0391-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Surgical Appliance Industries

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

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

FQL

Quantity affected

351896 pairs

Distribution

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

Date initiated

2011-10-07

Date posted

2012-01-11

Date terminated

2013-03-05

Location

Cincinnati, OH