Recall Z-2029-2012— Gulf Fiberoptics, Inc.

Name: FDA recall Z-2029-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-09

Class II · Terminated

Class II FDA medical device recall by Gulf Fiberoptics, Inc., initiated 2012-04-09, terminated 2013-03-07. FDA's recall record names no specific 510(k) clearance for this event. Product: GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.. Reason: The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference..

Recalling firm: Gulf Fiberoptics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-04-09
Terminated: 2013-03-07
Firm location: Oldsmar, FL, United States

Product description

GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.

Reason for recall

The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.

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