Date Initiated by Firm | January 08, 2003 |
Date Posted | January 30, 2003 |
Recall Status1 |
Terminated 3 on May 01, 2012 |
Recall Number | Z-0478-03 |
Recall Event ID |
25224 |
510(K)Number | K920358 |
Product Classification |
Balloon, Epistaxis - Product Code EMX
|
Product | Ultracell 8.0 cm Nasal Packing w/tube
Catalog #:10110-CT |
Code Information |
Lot Numbers: 063201 Exp. 5/2005 063202 Exp. 6/2005 063204 Exp. 7/2005 063206 Exp. 8/2005 063208 Exp. 11/2005 |
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 | 89.15 boxes |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = EMX
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