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U.S. Department of Health and Human Services

Class 2 Device Recall HealthLinkBIOPSY PUNCHES

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  Class 2 Device Recall HealthLinkBIOPSY PUNCHES see related information
Date Initiated by Firm March 18, 2013
Date Posted July 02, 2013
Recall Status1 Terminated 3 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 2
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 and Original Applicant = FRAY PRODUCTS CORP.
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