PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: February 13, 2013 Initiated: January 17, 2013 #Z-0744-2013

Product Description

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

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

Details

Recalling Firm
Carestream Health, Inc.
Units Affected
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.
Location
Rochester, NY

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Carestream Health, Inc.. Units affected: 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2013. Severity: Low. Recall number: Z-0744-2013.

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