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
FDA Recall Z-0744-2013 · Posted 2013-01-28
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Recalling FirmCarestream Health, Inc.
Recall StatusTerminated
Product CodeIWZ
Date Initiated2013-01-17
Date Terminated2016-05-18
Product Quantity101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
Reason for Recall
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 a
Firm Action
Carestream sent an Urgent Customer Notification and Field Corrective Action Letters dated January 17, 2013 and response form to the domestic consignees via UPS Overnight Mail. The letter identified the affected product, problem and actions to be taken. In addition, the consignees were instructed to complete the response form and fax it back to Carestream to fax # 585-323-7643. For questions or concerns customers were instructed to contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031.
Root Cause
Process change control
Distribution Pattern
US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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