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U.S. Department of Health and Human Services

Medical Device Recalls
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 Medical Device Recallssee related information
Date Initiated by FirmApril 09, 2012
Create DateJuly 18, 2012
Recall Status1 Terminated 3
Recall NumberZ-2029-2012
Recall Event ID 62408
ProductGMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
Recalling Firm/
Manufacturer		 Gulf Fiberoptics, Inc.
448 Commerce Blvd
Oldsmar FL 34677-2808
For Additional Information ContactNick Malure
813-855-6618
Manufacturer 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.
ActionThe firm, Gulf Fiberoptics, Inc., sent an "RECALL NOTIFICATION-PLEASE DO NOT DISCARD" letter dated April 09, 2012 to its customer via (traceable letter & email). A notification was put on the firm's website. The letter described the product, problem and actions to be taken. The distributors were instructed to determine the status of the product; remove existing product from service immediately and return to their company in a timely manner; send all returned GMF-RC65 cables to Gulf Fiberoptics; forward copies of the recall letters to their customers, ultimately the end user, and complete and return the attached Recall Worksheet Form for each GMF-RC65 cables regardless of its status via fax to: +1 813.855.6627; email to: difigueoa@gulffiberoptics.com or mail to : Gulf Fiberoptics, 448 Commerce Blvd, Oldsmar, FL 34677. The customers were instructed to remove the cables from service immediately, if they think they may have one of the listed cables; contact customer service at +1 813.855.6618 for serial number verification and for instructions to return this cable to Gulf Fiberoptics. If you have any questions regarding this voluntary recall, please contact your Customer Service representative at: +1813.855.6618 or by email at: difigueroa@gulffiberotpics.com.
Quantity in Commerce169 units
DistributionWorldwide distribution: USA (nationwide) including states of: AL, CA, CO, FL, MI, NC, NJ, NY, OH, PA, TN, TX and WI and country of: South Africa.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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