Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage:
FDA device recall Z-1247-2016 · posted 2016-03-24 · Terminated
Recall details
- Recalling firm
- Neurotherm, Inc.
- Reason for recall
- Straight needle labeled as a curved needle
- Action taken
- NeuroTherm notified consignees by telephone between February 2- March 15, 2013 about the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return devices.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GXI
- Quantity affected
- 135 cannulas (27 boxes/5)
- Distribution
- US Nationwide Distribution in the states of CA ,CO, OH, OR
- Date initiated
- 2013-02-26
- Date posted
- 2016-03-24
- Date terminated
- 2016-03-25
- Location
- Wilmington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA (K000073) | Mercury Medical | 2000-03-01 |