Z-2142-2014 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2014
- Initiation Date
- July 2, 2014
- Termination Date
- May 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1633 boxes
Product Description
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution.
Code Information
Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1