| Date Initiated by Firm |
May 02, 2003 |
| Date Posted |
February 24, 2004 |
| Recall Status1 |
Terminated 3 on July 07, 2012 |
| Recall Number |
Z-0541-04 |
| Recall Event ID |
26331 |
| Product Classification |
Frame, Spectacle - Product Code HQZ
|
| Product |
Product is Magnivision UltraLights reading glasses which have the dioptic power on the label and ''MAGNIVISION AN AMERICAN GREETINGS COMPANY Miramar, FL 33025'' |
| Code Information |
Product is not coded. |
Recalling Firm/
Manufacturer |
Magnivision, Inc.
3700 Commerce Pkwy.
Miramar FL 33025
|
| For Additional Information Contact |
Eleanor Chilson
954-986-9000 Ext. 3413
|
Manufacturer Reason
for Recall |
Possibility of eye injury from large temple tags on promotional sale product when customer tries them on in store.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm sent an e-mail dated 4/16/03 to their only direct wholesaler telling them to hold the product and followed up with a phone call infomring them of the retagging on 5/2/03 and a sufficient quantify of tags to relabel product at the retail level. Also they visited the wholesaler and retagged in house stock with the smaller tag. |
| Quantity in Commerce |
145884 |
| Distribution |
Product was distributed to a a wholesaler 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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