Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0624-03

NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in...

E Med Future / initiated 2002-08-15 / Terminated / root cause: manufacturing process

E Med Future Inc began a recall of NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in the law enforcement market or veterinary market on . The reason FDA records is "Their NeedleZap devices were not manufactured in accordance with the Quality System Regulations, and were shipped without an approved PMA". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0624-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
E Med Future
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.
Product code
MTV Sharps Needle Destruction Device
Reason for recall
Their NeedleZap devices were not manufactured in accordance with the Quality System Regulations, and were shipped without an approved PMA.
Root cause tag
manufacturing process
FDA root cause
Other
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.
Product codes and lots
The devices are not identified with lot numbers or serial numbers.