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U.S. Department of Health and Human Services

Class 3 Device Recall KODAK

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  Class 3 Device Recall KODAK see related information
Date Initiated by Firm January 17, 2013
Date Posted January 28, 2013
Recall Status1 Terminated 3 on May 18, 2016
Recall Number Z-0744-2013
Recall Event ID 64135
Product Classification Film, radiographic - Product Code IWZ
Product 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
Code Information Lot 2114596 (Exp. September 2014)
Recalling Firm/
Manufacturer		 Carestream Health, Inc.
1669 Lake Avenue
Rochester NY 14652-3401
For Additional Information Contact Christine Ehmann
585-627-6473
Manufacturer 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
FDA Determined
Cause 2		 Process change control
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.
Quantity in Commerce 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
Distribution US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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