Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0746-2012

DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150...

Eastman Kodak Company / initiated 2011-12-20 / Terminated / root cause: manufacturing process

Carestream Health, Inc. began a recall of 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... on . The reason FDA records is "Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0746-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Eastman Kodak Company
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.
Product code
IWZ Film, Radiographic
Reason for recall
Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density.
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
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