Z-2143-2014 Class III Terminated
FDA device recall Z-2143-2014 was initiated by Carestream Health Inc. on July 2, 2014 and is designated Class III. 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 th… The recall status is terminated (terminated May 25, 2016). Affected quantity: 1633 boxes.
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
Ultra-speed Dental Film, Catalog Number/REF 834 8658, 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: 33301201, 33301202, 33301203, 333012 part unknown, 34301501