INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

FDA device recall Z-2142-2014 · posted 2014-08-01 · Terminated

Recall details

Recalling firm

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.

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.

Root cause

Package design/selection

Status

Terminated

Product code

IWZ

Quantity affected

1633 boxes

Distribution

Worldwide Distribution.

Date initiated

2014-07-02

Date posted

2014-08-01

Date terminated

2016-05-25

Location

Rochester, NY