FDAFDA · Food and drugs·Recall number Z-2142-2014
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Published August 13, 2014 · Recall initiated: July 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carestream Health Inc.
- Distributor
- Worldwide Distribution.
- Lot
- Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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