Recall Z-1608-2016— Applied Medical Technology Inc

Name: FDA recall Z-1608-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-17

Class II · Terminated

Class II FDA medical device recall by Applied Medical Technology Inc, initiated 2016-02-17, terminated 2016-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.. Reason: The firm received a complaint of an open pouch which breaches the sterilization validation..

Recalling firm: Applied Medical Technology Inc
Classification: Class II
Status: Terminated
Initiated: 2016-02-17
Terminated: 2016-10-27
Firm location: Brecksville, OH, United States

Product description

TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

Reason for recall

The firm received a complaint of an open pouch which breaches the sterilization validation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.