FDA-Device2015-05-06Class II
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.
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Hazard
A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
Sold states
Nationwide Distribution.
Affected count
90 Tuohy needles (9 cases of 10 each)
Manufactured in
3498 West 2400 South #1050, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1544-2015Don't want to check this manually?
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