Recall Z-1544-2015— Integra LifeSciences Corp. d.b.a. Integra Pain Management
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, initiated 2015-03-30, terminated 2015-06-24. It names one FDA 510(k) clearance: K854816. 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.. Reason: A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles..
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-30
- Terminated
- 2015-06-24
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
Data sourced from openFDA. This site is unofficial and independent of the FDA.