Z-0579-2015Class II

Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number...

Name: Z-0579-2015 Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number...
Creator: ArthroCare Medical Corporation
Published: 2014-10-27
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2014-10-27 / Terminated / root cause: packaging

FDA source

ArthroCare Medical Corporation began a recall of Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger... on 2014-10-27. FDA classified it as Class II and gives the reason as "Potential breach of sterile barrier due to defective product tray". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0579-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-27
Posted: 2014-12-16
Terminated: 2015-10-09
Recalling firm: ArthroCare Corporation
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential breach of sterile barrier due to defective product tray.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0579-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0579-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-10

Product code GEI

K083306Class IIModification to Arthrocare ArthrowandsArthrocare Corp. / cleared 2008-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)