Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 1
FDA device recall Z-0857-05 · posted 2005-06-01 · Terminated
Recall details
- Recalling firm
- Mick Radio Nuclear Instr Inc
- Reason for recall
- 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.
- Action taken
- 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).
- Root cause
- Other
- Status
- Terminated
- Product code
- IWF
- Quantity affected
- 327 cartons; RECALL EXPANSION: 926 cartons
- Distribution
- Medical facilities located nationwide, and distributors in Sweden, The Netherlands, Germany and the United Kingdom.
- Date initiated
- 2005-03-30
- Date posted
- 2005-06-01
- Date terminated
- 2012-08-22
- Location
- Mount Vernon, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICK 200-TP AND MICK TP NEEDLE (K890341) | Mick Radio-Nuclear Instruments, Inc. | 1989-03-14 |