Class 2 Device Recall Ultracell

• Date Initiated by Firm: January 08, 2003
• Date Posted: January 30, 2003
• Recall Status: Terminated on May 01, 2012
• Recall Number: Z-0482-03
• Recall Event ID: 25224
• 510(K)Number: K920357
• Product Classification: Ear Wick - Product Code KCN
• Product: Ultracell Ear Wick Fenestrated 9mm DIA x 15mm Catalog #: 30305-C
• Code Information: Lot Numbers: 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: 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: 33 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