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U.S. Department of Health and Human Services

Class 3 Device Recall KODAK TMAT G/RA Film

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  Class 3 Device Recall KODAK TMAT G/RA Film see related information
Date Initiated by Firm March 12, 2010
Date Posted April 08, 2010
Recall Status1 Terminated 3 on July 07, 2010
Recall Number Z-1315-2010
Recall Event ID 54981
Product Classification film, radiographic - Product Code IWZ
Product KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet Boxes FOLHAS/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904

Intended use: Imaging film
Code Information Lot 835 021
Recalling Firm/
Manufacturer		 Carestream Health, Inc.
150 Verona Street
Rochester NY 14608-1733
Manufacturer Reason
for Recall		 Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action A "MEDICAL DEVICE RECALL (VOLUNTARY)" letters and Response Forms (dated 3/12/10) were sent to the customers on 3/12/10 via Certified Mail, Return Receipt Requested. The foreign sales offices are being notified via e-mail (started on 3/12/10) so that they in turn can notify the foreign consignees of the recall action and report back to Carestream Health. The letter describes the products, problem and action to be taken by the customers. The customers should identify and remove from inventory shelves any product that is listed in the recall, complete and return the attached Product Information Form whether they have affected product or not by fax to Carestream Health Customer Service 1-800-445-9967. Carestream Health will organize the return through designated carriers and will pay for transportation; and supply replacement stock in a timely manner. If you have any questions, concerns, or product technical questions, please call or fax Customer Service or Technical support at 1-800-328-2910.
Quantity in Commerce 875 boxes
Distribution Worldwide distribution: USA and Puerto Rico, Australia, Canada, Chile, El Salvador, Honduras, and New Zealand
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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