Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall NEEDLEZAP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall NEEDLEZAP see related information
Date Initiated by Firm August 15, 2002
Date Posted March 06, 2003
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.
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
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.
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.
-
-