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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

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.
Recall Number Z-2029-2012
Classification Class II
Code Info 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
Product Distributed Qty 169 units
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.

Event Detail

Event Id 62408
Product Type Devices
Status Ongoing
Recalling Firm Gulf Fiberoptics, Inc.
City Oldsmar
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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