Recall Z-0857-05 ยท IWF Needle, Isotope, Gold, Titanium, Platinum
Mick Radio Nuclear Instr Inc
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 ca
| Date | Jun 1, 2005 (initiated Mar 30, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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). |
| Quantity | 327 cartons; RECALL EXPANSION: 926 cartons |
| Distribution | Medical facilities located nationwide, and distributors in Sweden, The Netherlands, Germany and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890341 | MICK 200-TP AND MICK TP NEEDLE Mick Radio-Nuclear Instruments, Inc., Mar 14, 1989 |