| 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 |
|---|
|
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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