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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
