Recall Z-1544-2015
Integra LifeSciences Corp. d.b.a. Integra Pain Management · initiated March 30, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot No. W1412086, Exp DEC-2017.
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.
FDA-determined 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.
Details
- Recall number
- Z-1544-2015
- Initiated
- March 30, 2015
- Posted by FDA
- April 29, 2015
- Terminated
- June 24, 2015
- Product code
- BSP – Needle, Conduction, Anesthetic (W/Wo Introducer)
- Quantity
- 90 Tuohy needles (9 cases of 10 each)
- Distribution
- Nationwide Distribution.
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT