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U.S. Department of Health and Human Services

Class 3 Device Recall Kodak DryView Laser Imaging Film

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 Class 3 Recall
Kodak DryView Laser Imaging Film
see related information
Date Posted January 13, 2012
Recall Status1 Open
Recall Number Z-0746-2012
Recall Event ID 60736
Product Classification Film, Radiographic - Product Code IWZ
Product DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150 Verona St, Rochester, New York 14608. General purpose radiography.
Code Information Roll 027689-212, slits A/B/C, cartridges 12 - 19 --- Lot Number: 027689212- A - 012 through -019 --- Lot Number: 027689212- B - 012 through -019 --- Lot Number: 027689212- C - 012 through -019
Recalling Firm/
Manufacturer
Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608-1733
Consumer Instructions No consumer action necessary
For Additional Information Contact Christine Ehmann
585-724-5974
Manufacturer Reason
for Recall
Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Carestream Health Inc. sent an "URGENT PRODUCT REMOVAL" letter dated December 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to identify, segregate, and return any affected product to the firm. A Product Information Form was attached to the letter for customers to complete and return via fax to 541-831-7101. Contact Technical Support at 1-800-328-2910 for questions regarding this notice.
Quantity in Commerce 24 cartridges
Distribution Worldwide Distribution-USA (nationwide) including the states of Alabama, Florida, Georgia, and Tennessee and the country of Australia.
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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