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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 64888
Product Type Devices
Status Ongoing
Recalling Firm Clorox Healthcare Holdings, LLC (dba HealthLink)
City Jacksonville
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-18
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy. 1232040, 1232039, 1232038, 1232037, 1232029, 1232027, 1232026, 1232025, 1232023, 1232022, 1232019, 1232018, 1232017, 1232016, 1232014, 1232012, 1232011, 1232008, 1232007, 1232006, 1231322, 1231321, 1231320, 1231315, 1226439, 1226438, 1226434, 1226433, 1226431, 1226430, 1226429, 1226428, 1226427, 1226426, 1226422, 1226420, 1226419, 1226418, 1226417, 1226415, 1226414, 1222301, 1222302, 1222303, 1222304, 1222305, 1222306, 1222307, 1222308, 1222309, 1222310, 1222311, 1222312, 1222313, 1222314, 1222315, 1222316, 1222317, 1222323, 1222324, 1222325, 1222326, 1222327, 1222328, 1222329, 1222330, 1222331, 1222332, 1222333, 1222334, 1222335, 1222336, 1222337, 1222338, 1222339, 1222001, 1217408, 1217407, 1217406, 1217405, 1217403, 1217402, 1217401, 1214505, 1213925, 1213922, 1213920, 1213919, 1213915, 1213914, 1213913, 1213912, 1213911, 1213909, 1213908, 1213904, 1213903, 1213902, 1213901, 1211614, 1211613, 1208728, 1208727, 1208726, 1208725, 1208724, 1208723, 1208722, 1208721, 1208720, 1207323, 1205328, 1205327, 1205326, 1205325, 1205324, 1205323, 1205322, 1205321, 1205320, 1205319, 1205318, 1205317, 1205316, 1205315, 1201925, 1201924, 1201923, 1201922, 1201921, 1201920, 1201919, 1201918, 1201917, 1201916, 1201915, 1201914, 1201913, 1201912, 1201911, 1201910, 1201909, 1200511, 1200319, 1134635, 1134634, 1134633, 1134632, 1134631, 1134630, 1134629, 1134628, 1134627, 1134626, 1134625, 1134624, 1129718, 1129329, 1129326, 1129325, 1129323, 1129322, 1129321, 1129320, 1129319, 1129318, 1129317, 1129316, 1129315, 1129314, 1128318, 1125622, 1125621, 1125620, 1125619, 1125618, 1125617, 1125616, 1125615, 1123516, 1123515, 1123514, 1123010, 1122921, 1122920, 1122919, 1122918, 1122917, 1122916, 1122915, 1122719, 1122718, 1122717, 1122716, 1121520, 1121519, 1121518, 1121517, 1121516, 1121515, 1120814, 1120727, 1120726, 1120725, 1120724, 1120723, 1120722, 1120721, 1120720, 1119923, 1119922, 1119921, 1119920, 1119919, 1119324, 1119323, 1119322, 1119321, 1119320, 1119319, 1118723, 1118722, 1118721, 1118720, 1118719, 1118718, 1118717, 1118716, 1118024, 1118023, 1118022, 1118021, 1118020, 1118019, 1118018, 1118017, 1118016, 1117410, 1117409, 1117408, 1117407, 1116714, 1116713, 1116712, 1116711, 1116710, 1116709, 1116418, 1116018, 1116017, 1116016, 1116015, 1116014, 1116013, 1113217, 1113216, 1112221, 1111807, 1111806, 1111805, 1111804, 1111518, 1111021, 1111020, 1111019, 1111018, 1111017, 1111016, 1110129, 1110128, 1110127, 1110126, 1110125, 1110124, 1110123, 1110122, 1109619, 1109618, 1109616, 1109018, 1109017, 1109016, 1109015, 1109014, 1108315, 1108314, 1108313, 1108312, 1108310, 1108309, 1108025, 1108024, 1108023, 1108022, 1108021, 1108020, 1106226, 1106225, 1105422, 1104210, 1104209, 1104208, 1104207, 1103919, 1102417, 1101819, 1101818, 1101817, 1101816, 1101815, 1100315, 1036135, 1036134, 1036133, 1036132, 1036131, 1036130, 1036129, 1036128, 1036126, 1036125, 1036124, 1036123, 1007711. Class II Due to lack of sterilization. 772,600 units Z-1656-2013
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy. 1103316, 1100626, 1100625, 1100624, 1100623, 1100622, 1100621, 1100620, 1100619, 1100618, 1100617, 1100616, 1100615, 1100318, 1100317, 1100316, 1034725, 1034724, 1033414, 1031515, 1028733, 1028732, 1028723, 1028722, 1028721, 1028720, 1028719, 1028718, 1028717, 1028716, 1028715, 1028721, 1028722, 1028723, 1028706, 1028707, 1023914, 1023913, 1023912, 1023910, 1023908, 1023907, 1023904, 1023903, 1023902, 1023901, 1023114, 1023111, 1023110, 1023107, 1023106, 1023110, 1023111, 1023112, 1023113, 1023114, 1023115, 1023116, 1023117, 1023118, 1023119, 1023120, 1023121, 1023122, 1019605, 1019606, 1019607, 1019608, 1019609, 1019610, 1019615, 1019616, 1019617, 1019618, 1019619, 1015217, 1015216, 1015215, 1013315, 1013219, 1001861, 1001860, 1001859, 1001858, 1001857, 1001856, 1001854, 1001852, 1001851, 1001850, 1001849, 1001848, 1001847, 1001846, 1001845, 1001843, 1001842, 1001841, 1000527, 1000526, 1000525, 1000518, 0935203, 0935202, 0935201, 0934418, 0931016, 0931015, 0931013, 0931012, 0931011, 0931009, 0931008, 0931007, 0931006, 0931005, 0931004, 0930216, 0930215, 0930214, 0930213, 0927931, 0927930, 0927929, 0927928, 0927927, 0927926, 0927924, 0927923, 0927922, 0927921, 0927920, 0927919, 0927128, 0927127, 0927126, 0927125, 0927124, 0927123, 0927122, 0927121, 0927120, 0926021, 0926020, 0926019, 0926018, 0926017, 0926016, 0926015, 0923116, 0923019, 0923018, 0923017, 0922516, 0922515, 0921533, 0921532, 0921529, 0921526, 0921525, 0921524, 0921523, 0921523, 0921522, 0921517, 0919724, 0919723, 0919722, 0919720, 0919719, 0919718, 0919715, 0919714, 0919713, 0919712, 0919711, 0917612, 0917321, 0917320, 0917319, 0917318, 0917316, 0916228, 0916227, 0916225, 0916223, 0916221, 0916219, 0914718, 0914717, 0914716, 0914715, 0913326, 0913324, 0913323, 0913322, 0913321, 0911413, 0911412, 0911410, 0911408, 0911403, 0911401, 0909922, 0909920, 0909918, 0909913, 0907901, 0907819, 0907720, 0907719, 0907618, 0905824, 0905821, 0905820, 0905819, 0905818, 0905815, 0905814, 0905813, 0905812, 0905807, 0905804, 0905802, 0904319, 0903522, 0901335, 0901333, 0901332, 0901329, 0901327, 0901325, 0901324, 0901323, 0901322, 0901321, 0901319, 0901318, 0834723, 0834721, 0834720, 0834719, 0834321, 0834318, 0834317, 0834316, 0832616, 0832615, 0832614, 0832213, 0832212, 0831918, 0831917, 0831916, 0831915, 0831714, 0831713, 0831017, 0831016, 0831015, 0830415, 0829817, 0829816, 0829815, 0829514, 0829513, 0828717, 0826812, 0826612, 0826314, 0825214, 0823812, 0823811, 0823214, 0823115, 0822618, 0822617, 0819320, 0819319, 0819318, 0819316, 0819315, 0815815, 0815813, 0815812, 0815811, 0815810, 0811616, 0811615, 0811614, 0807319, 0807315, 0807314, 0807115, 0806513, 0805919, 0805917, 0805121, 0805119, 0804519, 0803518, 0802418, 0801517, 0800320, 0800319, 0800318, 0800317, 0736517, 0735515, 0735117, 0734818, 0734817, 0734417, 0734117, 0732517, 0732317, 0729217, 0728817. Class II Due to lack of sterilization. 1,032,700 units Z-1655-2013
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy. 1232041; 1232030, 1232028, 1232024, 1232021, 1232020, 1232015, 1232013, 1232010, 1232009, 1231324, 1231323, 1226436, 1226435 1226432, 1226421, 1226416, 1226415, 1226416, 1226417, 1226418, 1226419, 1222318, 1222319, 1222320, 1222321, 1222322, 1217409, 1217404, 1213926, 1213924, 1213923, 1213921, 1213918, 1213917, 1213916, 1213910, 1213907, 1213906, 1213905, 1213115, 1208740, 1208739, 1208738, 1208737, 1208736, 1208735, 1208734, 1208733, 1208732, 1208731, 1208730, 1208729, 1205343, 1205342, 1205341, 1205340, 1205339, 1205338, 1205337, 1205336, 1205335, 1205334, 1205333, 1205332, 1205331, 1205330, 1205329, 1203217, 1201930, 1201929, 1201928, 1201927, 1201926, 1134639, 1134638, 1134637, 1134636, 1129331, 1129330, 1129328, 1129327, 1129324, 1125634, 1125633, 1125632, 1125631, 1125630, 1125629, 1125628, 1125627, 1125626, 1125625, 1125624, 1125623, 1123522, 1123521, 1123520, 1123519, 1123517, 1123512, 1122926, 1122925, 1122924, 1122923, 1122922, 1122720, 1121521, 1119218, 1116715, 1116020, 1116019, 1113222, 1113221, 1113220, 1113219, 1113218, 1111812, 1111811, 1111810, 1111809, 1111808, 1111025, 1111024, 1111023, 1111022, 1110130, 1109622, 1109621, 1109620, 1109617, 1109020, 1109019, 1106224, 1106223, 1106222, 1106221, 1106220, 1106219, 1105421, 1105420, 1105419, 1105418, 1105417, 1105416, 1105415, 1104213, 1104212, 1104211, 1103825, 1103824, 1103320, 1103319, 1103318, 1103317, 1102611, 1102610, 1101218, 1035518, 1034723, 1034722, 1034721, 1034720, 1034719, 1030620, 1030619, 1030618, 1030617, 1030616, 1030615, 1028731, 1028730, 1028729, 1028728, 1028727, 1028726, 1028725, 1028724, 1028716, 1028717, 1028718, 1028719, 1028720, 1027217, 1027216, 1023916, 1023915, 1023911, 1023909, 1023906, 1023905, 1023113, 1023112, 1023109, 1023108, 1023107, 1023108, 1023109, 1019602, 1019603, 1019604, 1019611, 1019612, 1019613, 1019614, 1015220, 1015219, 1015218, 1013316, 1013220, 1013218, 1009814, 1001855, 1001853, 1001844, 1001840, 1001839, 1001838, 1001837, 1001836, 1001835, 1001834, 1001833, 1001832, 1001831, 1001830, 1001829, 1001828, 1001827, 1001826, 1001825, 1001824, 1001823, 1000524, 1000523, 1000522, 1000521, 1000520, 1000519, 1000517, 0935206, 0935205, 0935204, 0934417, 0934416, 0934415, 0931612, 0931010, 0931003, 0931002, 0931001, 0927925, 0927130, 0927129, 0926022, 0923119, 0923118, 0923117, 0923115, 0923016, 0921531, 0921530, 0921528, 0921527, 0919721, 0919717, 0919716, 0919710, 0917317, 0916226, 0916224, 0916222, 0916220, 0916218, 0913330, 0913329, 0913328, 0913327, 0911411, 0911409, 0911407, 0911406, 0911405, 0911404, 0911402, 0909921, 0909919, 0909917, 0909916, 0909915, 0909914, 0909912, 0907718, 0907620, 0907619, 0905817, 0905816, 0905811, 0905810, 0905809, 0905808, 0905806, 0905805, 0905803, 0905801, 0903521, 0903520, 0903519, 0903517, 0901334, 0901331, 0901330, 0901328, 0901326, 0901320, 0901317, 0834724, 0834722, 0834718, 0834322, 0834320, 0834319, 0834315, 0832613, 0832215, 0832214, 0831715, 0831018, 0829515, 0828716, 0828715, 0828416, 0826813, 0826613, 0825216, 0825215, 0823114, 0822809, 0822616, 0819321, 0819317, 0815814, 0811613, 0809412, 0807318, 0807317, 0807316, 0807313, 0807312, 0807114, 0807113, 0806515, 0806514, 0805921, 0805918, 0805719, 0805718, 0805717, 0804518, 0804517, 0802419, 0801917, 0801518. Class II Due to lack of sterilization. 1,044,600 units Z-1654-2013
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