Medical device recalls Moderate risk

Integra LifeSciences Corp. d.b.a. Integra Pain Management recalls Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrat…

Recall date
March 30, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1544-2015
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Sold / distributed
Nationwide Distribution.

Why it was recalled

A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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