Class 2 Device Recall HealthLinkBIOPSY PUNCHES

• Date Initiated by Firm: March 18, 2013
• Date Posted: July 02, 2013
• Recall Status: Terminated on February 25, 2014
• Recall Number: Z-1654-2013
• Recall Event ID: 64888
• 510(K)Number: K921822
• Product Classification: Punch, surgical - Product Code LRY
• Product: HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Clorox Healthcare Holdings, LLC (dba HealthLink); 3611 Saint Johns Bluff Rd S Ste 1; Suite 1; Jacksonville FL 32224-2679
• For Additional Information Contact: Chris Timmons; 904-996-7758
• Manufacturer Reason for Recall: Due to lack of sterilization.
• FDA Determined Cause: Packaging change control
• Action: On March 19, 2013, HealthLink sent their customers letters instructing them to do the following: 1) Screen their inventory and quarantine the product. 2) Notify all customers that received the affected products and ask them to return the lots to their firm. 3) Complete the attached form and return the lots to HealthLink Distribution center. For further assistance, customers were directed to call customer service at 1-800-638-2625.
• Quantity in Commerce: 1,044,600 units
• Distribution: 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.
• 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.

• 510(K) Database: 510(K)s with Product Code = LRY