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.
This recall has been terminated (originally issued April 29, 2015).
- Recall Initiated
- March 30, 2015
- Posted
- April 29, 2015
- Terminated
- June 24, 2015
- Recall Number
- Z-1544-2015
- Quantity
- 90 Tuohy needles (9 cases of 10 each)
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot No. W1412086, Exp DEC-2017.
Root Cause
Employee error
Action Taken
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.