Recall Z-1544-2015 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Integra LifeSciences Corp. d.b.a. Integra Pain Management
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.
| Date | Apr 29, 2015 (initiated Mar 30, 2015) |
| Status | Terminated |
| Reason | A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles. |
| Root cause | Employee error |
| Action | US Consignees were notified by an Urgent: Voluntary Medical Device Recall letter on 3/30/15 delivered by traceable courier service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review their inventory, identify affected products, and immediately stop use and remove them from service. Customers are to complete the attached form and return via mail or fax. Upon receipt of the form, Customer Service will provide an RMA number and directions for returning the affected products to the firm. Customers should contact Customer Service |
| Quantity | 90 Tuohy needles (9 cases of 10 each) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854816 | EPIDURAL ANESTHESIA NEEDLES Reganes, Inc., Dec 19, 1985 |