INSIGHT Dental Film recall: Labeling Error
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Why was INSIGHT Dental Film recalled?
The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1
- Product
- INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
- Recalling firm
- Carestream Health Inc.
- Quantity
- 1633 boxes
- Distribution
- Worldwide Distribution.
- Recall date
- August 13, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)