Reported Dec 17, 2014 · Terminated
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient…
ArthroCare Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ArthroCare Medical Corporation · 7000 W William Cannon Dr · Austin, TX · 78735-8509
Is this the product you have?
- Model Number ASHA4730-01Ambient HipVac 50 Wand with Integrated Finger
- Switches and Model Number ASHA5050-01Ambient 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
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 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 ASHA5050-01(KVac) — lot numbers: 1044887, 1050012, 1053720, 1054965, 1055700, 1068390, 1068391, 1068392, 1068393, 1076028, 1078916, 1078918 - Amount recalled
- 23,119 devices
Where it was sold
- Nationwide
Why it was recalled
Potential breach of sterile barrier due to defective product tray.
This product could cause temporary or reversible health problems — stop using it.
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