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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/
Ultracell Medical Technologies
183 Providence
North Stonington, Connecticut 06359
For Additional Information Contact Audrey Vitale
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