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U.S. Department of Health and Human Services

Class 2 Device Recall Graczyk Inc. (OEM)

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 Class 2 Recall
Graczyk Inc. (OEM)
see related information
Date Posted January 30, 2003
Recall Status1 Open
Recall Number Z-0489-03
Recall Event ID 25224
Product Classification Sponge, Ophthalmic - Product Code HOZ
Product Lasik Spears Blunt (5) Catalog #: U/S32-100
Code Information Lot Number: 062308 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 126 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

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