Device 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
Z-0744-2013
Product summary
- Event
- Event 64135
- Status
- Terminated
- Classification
- Class III
- Quantity
- 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
- Official record key
device-enforcement:Z-0744-2013
Official wording
Reason: 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
Code information: Lot 2114596 (Exp. September 2014)
Distribution pattern: US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
Derived failure modes
-
Labeling or packaging
label. The expiration dating symbol is missing