The Recall Desk
LowFDA (Devices)·Z-0744-2013·Announced 2013-02-13

Carestream Recalls Dental Film Due to Missing Label Symbols

Carestream Health is recalling specific lots of Kodak Insight Dental Film because the clear carton labels are missing required symbols and manufacturer information.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is limited to missing symbols on the packaging label, which is a documentation and packaging problem.

Plain-English summary

Carestream Health, Inc. is recalling 101 cartons of KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film (Model Number IP21S, REF/Catalog Number 8118226). The affected product is identified by Lot 2114596 with an expiration date of September 2014. The recall involves 95 cartons distributed domestically and 6 cartons distributed to Canada.

The recall was initiated because the clear carton labels are missing specific required symbols and manufacturing information. Specifically, the expiration dating symbol, the lot symbol, and the manufacturer symbol, name, address, and country of origin are missing from the clear carton label. However, the actual expiration date and lot number are present, and all remaining symbols and information are located on the case label.

The product was distributed nationwide in the United States, including California, Florida, Texas, Illinois, Indiana, Maryland, and Pennsylvania, as well as to Canada. Consumers and dental professionals should check their inventory for this specific lot number and model. If found, the product should be returned to the distributor or Carestream Health for credit or replacement.

The recalled product

Product
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 2114596 (Exp. September 2014)

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically: