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U.S. Department of Health and Human Services

Class 3 Device Recall Drystar Mammo

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  Class 3 Device Recall Drystar Mammo see related information
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/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Jeffery A. Jedlicka
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

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.