Class 3 Device Recall Cronex

• Date Initiated by Firm: February 16, 2006
• Date Posted: April 11, 2006
• Recall Status: Terminated on June 22, 2006
• Recall Number: Z-0754-06
• Recall Event ID: 34890
• Product Classification: Medical Screen X-Ray Film - Product Code JAC
• Product: Cronex 10T, 14x17, Medical Screen Film, X-ray Film, 100 Sheet Box
• Code Information: Product Code: LF5Ha, Manufacturing batch or Lot: 79340139
• Recalling Firm/ Manufacturer: AGFA Corp.; 10 S Academy St; Greenville SC 29601-2632
• For Additional Information Contact: Ray B. Myers Ph.D.; 864-864-1827
• Manufacturer Reason for Recall: A localized fog pattern appears on the film.
• FDA Determined Cause: Other
• Action: Consignees were notified by telephone on 02/16/2006.
• Quantity in Commerce: 712 stacks (total includes all types of film)
• Distribution: AL, AZ, CA, CO, FL, GA, IN, MA, MI, NC, NJ, NY, OR, SC, TN, TX, WA, VA and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.