Class 2 Device Recall GMFRC65 Replacement Surgical Headlight Cable for Cogent Microlink.

• Date Initiated by Firm: April 09, 2012
• Date Posted: July 18, 2012
• Recall Status: Terminated on March 07, 2013
• Recall Number: Z-2029-2012
• Recall Event ID: 62408
• Product Classification: Light, surgical, fiberoptic - Product Code FST
• Product: GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. ; ; GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
• Code Information: Serial Numbers: 12208, 12209 12204 12855 13023 13102 12203 12210 13117 13258 12202 12201 13416 13489 12199, 13488 12198 12200 13499 12195, 13612 13607 14186 13610 13609 14184 14059, 14060 14164, 14165 14185 14190 14330 14333 14395, 14396, 14397 14485 14509 14508 14559 14580 14670, 14671, 14672 14680, 14681 14690 - 14699 14909, 14910 14983 14986 14985 14987 14984 14988 15708 14989 14990 16209 16207 16206 16208 16211 16489 16648 17466 16488 16487 16793, 16794 16237 17051 17052 17186, 17187, 17188 17014 17288-17289 17476 17467 17464 17321-17324 17860-17861 17899 17898 17506 18452 18451 17903 17901 17889 17891 17890 17888 20854 20860 17902 21095-21096 20856, 20858, 20859 20420 17900 20387 20855, 20857 20386 20357, 20358 20359 20029, 20030, 20360, 23813, 23814 20385 24462 24597, 24600 24663 25321 25513, 25518 25515 20384 26650, 25514, 25516, 25517 26651, 26652 26653, 26654, 26655 20388 20383 27460 - 27463 20388 20383 27825, 27826 28661, 28664
• Recalling Firm/ Manufacturer: Gulf Fiberoptics, Inc.; 448 Commerce Blvd; Oldsmar FL 34677-2808
• For Additional Information Contact: Nick 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.
• FDA Determined Cause: Device Design
• Action: The 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 Commerce: 169 units
• Distribution: Worldwide 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.
• Total Product Life Cycle: TPLC Device Report

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.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.