Recall Z-0744-2013— Carestream Health, Inc.
Class III · Terminated
Class III FDA medical device recall by Carestream Health, Inc., initiated 2013-01-17, terminated 2016-05-18. FDA's recall record names no specific 510(k) clearance for this event. 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. 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.
- Recalling firm
- Carestream Health, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-01-17
- Terminated
- 2016-05-18
- Firm location
- Rochester, NY, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.