Class 2 Device Recall Integra Long Epidural Steroid Injection Needle (Tuohy Needle)

• Date Initiated by Firm: May 01, 2015
• Date Posted: July 09, 2015
• Recall Status: Terminated on December 04, 2015
• Recall Number: Z-2056-2015
• Recall Event ID: 71147
• 510(K)Number: K854816
• Product Classification: Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
• Product: Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. ; Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.
• Code Information: W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management; 3498 West 2400 South #1050; Salt Lake City UT 84119
• For Additional Information Contact: Mr. David E. Gronostajski; 609-936-6822
• Manufacturer Reason for Recall: Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch).
• FDA Determined Cause: Labeling design
• Action: Integra sent an Urgent Voluntary Medical Device Recall letter dated May 1, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Integra is asking customers to do the following: 1. Review your inventory and determine if you have Tuohy Needle, 20 Gauge X 5 inches (Cat. No. PITRW2050) with an affected Lot Number that is listed on page 2. If so, stop using them immediately and remove them from service. 2. Complete the attached form. If you do not have affected product, check the box:  I do not have any product(s) with a Lot Number from the list below. 3. If you do have affected product, check the box:  I do have product(s) with a Lot Number from the list below. 4. Complete the other information on the form and return it by email or fax as indicated on the form. Keep a copy of the form for your records. When your form is received, Customer Service will contact you and provide an RMA number and directions to return and replace the affected products. Should you have any questions regarding these instructions, please contact Customer Service at 1-800-241-2210. For questions regarding this recall call 609-936-6822.
• Quantity in Commerce: 123 Tuohy needles
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BSP and Original Applicant = REGANES, INC.