Device product
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.
Z-1544-2015
Product summary
- Event
- Event 70873
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tuohy needles (9 cases of 10 each)
- Official record key
device-enforcement:Z-1544-2015
Official wording
Reason: A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
Code information: Lot No. W1412086, Exp DEC-2017.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.