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U.S. Department of Health and Human Services

Class 2 Device Recall HipVac and KVac

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  Class 2 Device Recall HipVac and KVac see related information
Date Initiated by Firm October 27, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on October 09, 2015
Recall Number Z-0579-2015
Recall Event ID 69667
510(K)Number K083306  K141814  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches.

The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Code Information Model Number ASHA4730-01 (HipVac) lot numbers: 1021255, 1021620, 1022188, 1022482, 1022636, 1023089, 1024067, 1025482, 1025480, 102481, 1025764, 1025765, 1026875, 1027163, 1027702, 1028327, 1029265, 1030025, 1031353, 1031759, 1031760, 1032765, 1032766, 1033773, 1033974, 1034227, 1034451, 1035036, 1035295, 1038550, 1039318, 1039903, 1042371, 1042370, 1043421, 1044678, 1045361, 1046599, 1047067, 1050441, 1053407, 1053408, 1052669, 1054471, 1056213, 1057010, 1055117, 1058810, 1058291, 1059396, 1061007, 1061008, 1064276, 1064641, 1065989, 1070710, 1070711, 1071321, 1071322, 1071360, 1071361, 1073431, 1073432, 1074079, 1074140, 1076027, 1077459, 1078013, 1078911  Model Number ASHA5050-01 (KVac) lot numbers: 1044887, 1050012, 1053720, 1054965, 1055700, 1068390, 1068391, 1068392, 1068393, 1076028, 1078916, 1078918
Recalling Firm/
Manufacturer		 ArthroCare Medical Corporation
7000 W William Cannon Dr
Austin TX 78735-8509
For Additional Information Contact
512-391-3900
Manufacturer Reason
for Recall		 Potential breach of sterile barrier due to defective product tray.
FDA Determined
Cause 2		 Package design/selection
Action The firm notified their consignees on 10/29/14 via letter with a response form included. The letter requested the consignees discontinue use of the device and return it to the vendor.
Quantity in Commerce 23,119 devices
Distribution Worldwide Distribution-US (nationwide) and the countries of Austria, Australia, Belgium, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Ireland, Malaysia, Netherlands, Norway, Poland, Spain, South Africa, Sweden, Switzerland, Turkey, and UK.
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 = GEI and Original Applicant = ARTHROCARE CORP.
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