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.
Recall
- Recall Number
- Z-0857-05
- Event Number
- 32046
- Firm
- Mick Radio Nuclear Instr Inc
- FEI Number
- 2431392
- Product Code
- IWF
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 30, 2005
- Posted
- June 1, 2005
- Terminated
- August 22, 2012
- Address
- 521 Homestead Avenue, Mount Vernon, NY, 10550-4619
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.
Some of the Mick TP Prostate Seeding Needles do not fit properly into the Mick 200-TPV Applicator. Firm received one complaint during use of the Mick 200 TPV Applicator.
Recall Notices (dated 3/30/05) were sent to the consignees by First Class Mail on 3/30/05. Follow-up phone calls to the consignees were initiated on 4/22/05. Recall was expanded for 7 additional lots, and recall notices (dated 8/09/05) were sent to the direct consignees (medical facilities).
Medical facilities located nationwide, and distributors in Sweden, The Netherlands, Germany and the United Kingdom.
327 cartons; RECALL EXPANSION: 926 cartons