Recall Z-2056-2015 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), 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
| Date | Jul 9, 2015 (initiated May 1, 2015) |
| Status | Terminated |
| Reason | 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). |
| Root 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 Lo |
| Quantity | 123 Tuohy needles |
| 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 |