INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
- Company
- Carestream Health, Inc.
- Recall Initiated
- July 2, 2014
- Posted
- August 1, 2014
- Terminated
- May 25, 2016
- Recall Number
- Z-2142-2014
- Quantity
- 1633 boxes
- Firm Location
- Rochester, NY
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
Worldwide Distribution.
Lot / Code Info
Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1
Root Cause
Package design/selection
Action Taken
Recall notices were mailed to US Customers via overnight carrier on 07/02/2014. Customers are asked to complete an inventory of goods to be returned which will be ultimately destroyed by recalling company. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031.