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U.S. Department of Health and Human Services

Class 2 Device Recall Ultracell

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  Class 2 Device Recall Ultracell see related information
Date Initiated by Firm January 08, 2003
Date Posted January 30, 2003
Recall Status1 Terminated 3 on May 01, 2012
Recall Number Z-0479-03
Recall Event ID 25224
510(K)Number K9230358  
Product Classification Balloon, Epistaxis - Product Code EMX
Product Ultracell Classic Anatomical Nasal Packing w/Tube (pediatric)
Catalog # 10126-CT
Code Information Lot Number:   063204 Exp. 7/2005 
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 6 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.
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