Device Recall Mick TP Prostate Seeding Needle

  • Model / Serial
    Lots: M121504-07 (Exp. 12/15/09), M012605-01 (Exp. 1/26/10), M012805-01 (Exp. 1/28/10); --- 8/09/05 RECALL EXPANSION (7 Lots): M110204-01 (Exp. 11/02/09), M110204-04 (Exp. 11/02/09), M110504-02 (Exp. 11/05/09), M120804-01 (Exp. 12/08/09), M120904-01 (Exp. 12/09/09), M121004-03 (Exp. 12/10/09), M121404-01 (Exp. 12/14/09)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities located nationwide, and distributors in Sweden, The Netherlands, Germany and the United Kingdom.
  • Product Description
    Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mick Radio Nuclear Instr Inc, 521 Homestead Avenue, Mount Vernon NY 10550-4619
  • Source
    USFDA