Date Initiated by Firm |
March 02, 2010 |
Create Date |
June 26, 2015 |
Recall Status1 |
Terminated 3 on February 14, 2012 |
Recall Number |
Z-0916-2012 |
Recall Event ID |
60762 |
Product Classification |
Film, radiographic - Product Code IWZ
|
Product |
Drystar Mammo.
Display of Mammographic images. |
Code Information |
ABC Code: EWCAK, size 8x10 inch Manufacturing lot: Emulsion Number: 36760074, cutting plan: B1AW1 |
Recalling Firm/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
|
For Additional Information Contact |
Jeffery A. Jedlicka 864-421-1815
|
Manufacturer Reason for Recall |
Labeling problem
|
FDA Determined Cause 2 |
Error in labeling |
Action |
The firm, AGFA Corporation spoke to the customer directly via telephone concerning the mislabeled affected products. The firm also contacted the customer via e-mail on April 13, 2011 explaining the outcome of the customer complaint. Replacement product was sent to the customer. |
Quantity in Commerce |
2 boxes |
Distribution |
Product distributed in Florida. |
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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