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.
FDA Recall Z-1544-2015 · Posted 2015-04-29
Recall StatusTerminated
Product CodeBSP
Date Initiated2015-03-30
Date Terminated2015-06-24
Product Quantity90 Tuohy needles (9 cases of 10 each)
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.
Firm 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 at 1-800-241-2210 with any questions regarding the instructions.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.