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Terminated

Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

FDA Recall Z-2143-2014 · Posted 2014-08-01

Recalling FirmCarestream Health Inc.
Recall StatusTerminated
Product CodeIWZ
Date Initiated2014-07-02
Date Terminated2016-05-25
Product Quantity1633 boxes

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.

Firm Action

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.

Root Cause

Package design/selection

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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