Date Initiated by Firm |
August 08, 2011 |
Date Posted |
January 11, 2012 |
Recall Status1 |
Terminated 3 on September 27, 2012 |
Recall Number |
Z-0618-2012 |
Recall Event ID |
60049 |
510(K)Number |
K082980
|
Product Classification |
Electrosurgical, cutting ; coagulation ; accessories - Product Code GEI
|
Product |
CoVac 50 Product Number AS2530-01 is an ablation wand
Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. |
Code Information |
Lot Numbers 3018831-2 and 3014221 |
Recalling Firm/ Manufacturer |
Innovatech Medical Resources L.P. 5455 Honeysuckle Road Midlothian TX 76065
|
Manufacturer Reason for Recall |
Product is being removed from the field due to an over-label issue.
|
FDA Determined Cause 2 |
Reprocessing Controls |
Action |
Innovatech Medical Resources L.P. decided to recall all products resterilized and overlabeled at their facility. A firm representative would visit each customer and request that they remove the overlabeled product from their shelves and secure it. Customers could call the MSI office to get a RMA (Return Materials Authorization) for a refund on this product.
For questions regarding this recall call 817-714-9066. |
Quantity in Commerce |
Lot Number (QTY): 3018831-2 (1 unit) and 3014221 (1 unit) |
Distribution |
Nationwide Distribution including Texas |
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.
|