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U.S. Department of Health and Human Services

Class 2 Device Recall Ultracell

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 Class 2 Recall
Ultracell
see related information
Date Posted January 30, 2003
Recall Status1 Open
Recall Number Z-0490-03
Recall Event ID 25224
Product 8.0 cm Nasal Classic Anatomical Nasal w/tube Catalog #:10120-CT
Code Information Lot Numbers: 063204 Exp. 7/2005 063206 Exp. 8/2005 063208 Exp. 11/2005
Recalling Firm/
Manufacturer
Ultracell Medical Technologies
183 Providence
North Stonington, Connecticut 06359
For Additional Information Contact Audrey Vitale
860-599-4883
Manufacturer Reason
for Recall
Sterility of the device is compromised
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 98.30 boxes
Distribution Nationwide

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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