Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0744-2013 — 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

U.S. FDA — Device Enforcement · United States · 2013-01-17 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0744-2013
Date of alert
2013-01-17
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Carestream Health, Inc.
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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