Z-0744-2013Class III

KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog...

Name: Z-0744-2013 KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog...
Creator: Carestream Health, Inc.
Published: 2013-01-17
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2013-01-17 / Terminated / root cause: labeling and UDI

FDA source

Carestream Health, Inc. began a recall of KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental... on 2013-01-17. FDA classified it as Class III and gives the reason as "Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0744-2013
Classification: Class III
Status: Terminated
Initiated: 2013-01-17
Posted: 2013-01-28
Terminated: 2016-05-18
Recalling firm: Eastman Kodak Company
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
Product code: IWZ Film, Radiographic
Reason for recall: Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: Carestream sent an Urgent Customer Notification and Field Corrective Action Letters dated January 17, 2013 and response form to the domestic consignees via UPS Overnight Mail. The letter identified the affected product, problem and actions to be taken. In addition, the consignees were instructed to complete the response form and fax it back to Carestream to fax # 585-323-7643. For questions or concerns customers were instructed to contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031.
Quantity in commerce: 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
Distribution: US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
Product codes and lots: Lot 2114596 (Exp. September 2014)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0744-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0744-2013	Class III	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04

Product code IWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)