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