| Date Initiated by Firm | August 15, 2002 |
|---|
| Date Posted | March 06, 2003 |
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| Recall Status1 |
Terminated 3 on February 05, 2004 |
| Recall Number | Z-0624-03 |
|---|
| Recall Event ID |
25039 |
| Product Classification |
Sharps Needle Destruction Device - Product Code MTV
|
| Product | NEEDLEZAP, a battery operated needle destruction device.
The product is labeled and marketed for use only in the law enforcement market or veterinary market. |
|---|
| Code Information |
The devices are not identified with lot numbers or serial numbers. |
| FEI Number |
3003763354
|
Recalling Firm/
Manufacturer |
E Med Future Inc
794 Morrison Road
Columbus OH 43230
|
Manufacturer Reason
for Recall | Their NeedleZap devices were not manufactured in accordance with the Quality System Regulations, and were shipped without an approved PMA. |
|---|
FDA Determined
Cause 2 | Other |
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| Action | On 8/15/2002, the firm contacted their largest distributor by telephone and instructed them to stop distribution and to place all remaining devices in quarantine until further notice. On 3/20/2003, the firm mailed recall notices to all direct accounts asking for the device to be returned. |
|---|
| Quantity in Commerce | 1,572 devices |
|---|
| Distribution | The devices were shipped to customers located nationwide. The product was also distributed into Canada, Greece and Ireland. |
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| 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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