Reported Feb 13, 2013 · Terminated
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number…
Carestream Health, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health, Inc. · 1669 Lake Avenue · Rochester, NY · 14652-3401
Is this the product you have?
- KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog
- Number 8118226 --- COMMON/USUAL NAMEDental Intraoral Radiographic Film -- 20 cartons of 80 packets
- Product UsageDental intraoral radiography
- Lot codes and dates
- Lot 2114596 (Exp. September 2014)
- Amount recalled
- 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
Where it was sold
Why it was 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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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