Date Initiated by Firm |
June 06, 2003 |
Date Posted |
July 03, 2003 |
Recall Status1 |
Terminated 3 on July 23, 2003 |
Recall Number |
Z-0981-03 |
Recall Event ID |
26534 |
510(K)Number |
K993154
|
Product Classification |
Powered Laser Surgical Instrument - Product Code GEX
|
Product |
A.R.C. Laser Photolysis Probe/Handpiece |
Code Information |
Part Number: 1A55LM02 Catalog Number: LY11002 |
Recalling Firm/ Manufacturer |
A.R.C. Laser Corp 2500 South Decker Lake Blvd. Suite 6 Salt Lake City UT 84119
|
For Additional Information Contact |
801-972-1311
|
Manufacturer Reason for Recall |
Product may not have been properly sterilized.
|
FDA Determined Cause 2 |
Other |
Action |
The 5 consignees were notified by phone on 06/06/2003, followed by fax and letter notification on 06/10/2003. |
Quantity in Commerce |
370 units |
Distribution |
IN, NY, PA, TX. |
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 = GEX and Original Applicant = A.R.C. LASER CORP.
|