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Terminated

NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in the law enforcement market or veterinary market.

FDA Recall Z-0624-03 · Posted 2003-03-06

Recalling FirmE Med Future Inc
Recall StatusTerminated
Product CodeMTV
Date Initiated2002-08-15
Date Terminated2004-02-05
Product Quantity1,572 devices

Reason for Recall

Their NeedleZap devices were not manufactured in accordance with the Quality System Regulations, and were shipped without an approved PMA.

Firm 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.

Root Cause

Other

Distribution Pattern

The devices were shipped to customers located nationwide. The product was also distributed into Canada, Greece and Ireland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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