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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-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/
Ultracell Medical Technologies
183 Providence
North Stonington CT 06359
For Additional Information Contact Audrey Vitale
Manufacturer Reason
for Recall
Sterility of the device is compromised
FDA Determined
Cause 2
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

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 = EMX and Original Applicant = ULTRACELL MEDICAL TECHNOLOGIES, INC.