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Z-0579-2015 Class II Terminated

Recalled by ArthroCare Medical Corporation — Austin, TX

FDA device recall Z-0579-2015 was initiated by ArthroCare Medical Corporation on October 27, 2014 and is designated Class II. Reason for recall: Potential breach of sterile barrier due to defective product tray. The recall status is terminated (terminated October 9, 2015). Affected quantity: 23,119 devices.

Recall Details

Product Type: Devices
Report Date: December 17, 2014
Initiation Date: October 27, 2014
Termination Date: October 9, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,119 devices

Product Description

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.

Reason for Recall

Potential breach of sterile barrier due to defective product tray.

Distribution Pattern

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.

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

Other recalls by ArthroCare Medical Corporation

Z-1832-2015 Class II — EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAN (May 15, 2015)
Z-1833-2015 Class II — PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA (May 15, 2015)
Z-1323-2015 Class II — Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is (February 20, 2015)
Z-0652-2014 Class II — Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013- (December 9, 2013)