| Class 3 Device Recall Curix | |
Date Initiated by Firm | February 16, 2006 |
Date Posted | April 11, 2006 |
Recall Status1 |
Terminated 3 on June 22, 2006 |
Recall Number | Z-0755-06 |
Recall Event ID |
34890 |
Product Classification |
Medical Screen X-Ray Film - Product Code JAC
|
Product | Curix 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 Contact | Ray B. Myers Ph.D. 864-864-1827 |
Manufacturer Reason for Recall | A localized fog pattern appears on the film. |
FDA Determined Cause 2 | 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 |
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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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