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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 64135
Product Type Devices
Status Ongoing
Recalling Firm Carestream Health, Inc.
City Rochester
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-17
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography Lot 2114596 (Exp. September 2014) Class II The company discovered that some cartons of KODAK INSIGHT with SureSoft Packets Dental Film Catalog Number 8118226 have missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only associated with the clear carton label. 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons Z-0744-2013