Date Initiated by Firm |
January 08, 2003 |
Date Posted |
January 30, 2003 |
Recall Status1 |
Terminated 3 on May 01, 2012 |
Recall Number |
Z-0480-03 |
Recall Event ID |
25224 |
510(K)Number |
K920357
|
Product Classification |
Ear Wick - Product Code KCN
|
Product |
Ultracell Ear Wick 9mm DIA x 15 mm Catalog #: 30300-C |
Code Information |
Lot Numbers: 063204 Exp. 7/2005 063206 Exp. 8/2005 063207 Exp. 10/2005 |
Recalling Firm/ Manufacturer |
Ultracell Medical Technologies 183 Providence North Stonington CT 06359
|
For Additional Information Contact |
Audrey Vitale 860-599-4883
|
Manufacturer Reason for Recall |
Sterility of the device is compromised
|
FDA Determined Cause 2 |
Other |
Action |
Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts. |
Quantity in Commerce |
105.5 boxes |
Distribution |
Nationwide |
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 = KCN and Original Applicant = ULTRACELL MEDICAL TECHNOLOGIES, INC.
|