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U.S. Department of Health and Human Services

Class 3 Device Recall Curix

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 Class 3 Device Recall Curixsee related information
Date Initiated by FirmFebruary 16, 2006
Date PostedApril 11, 2006
Recall Status1 Terminated 3 on June 22, 2006
Recall NumberZ-0755-06
Recall Event ID 34890
Product Classification Medical Screen X-Ray Film - Product Code JAC
ProductCurix Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box
Code Information Product Code; EKQEG, Manufacturing Batch or Lot: 79340029
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information ContactRay B. Myers Ph.D.
864-864-1827
Manufacturer Reason
for Recall
A localized fog pattern appears on the film.
FDA Determined
Cause 2
Other
ActionConsignees were notified by telephone on 02/16/2006.
Quantity in Commerce712 stacks (total includes all types of film)
DistributionAL, AZ, CA, CO, FL, GA, IN, MA, MI, NC, NJ, NY, OR, SC, TN, TX, WA, VA and Canada
Total Product Life CycleTPLC 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.
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