🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: July 2, 2014 Carestream Health Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2142-2014

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