Home / Recalls / Integra LifeSciences Corp. d.b.a. Integra Pain Management / Z-2056-2015

Z-2056-2015 Class II Terminated

Recalled by Integra LifeSciences Corp. d.b.a. Integra Pain Management — Salt Lake City, UT

Recall Details

Product Type
Devices
Report Date
July 15, 2015
Initiation Date
May 1, 2015
Termination Date
December 4, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
123 Tuohy needles

Product Description

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.

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).

Distribution Pattern

Nationwide Distribution

Code Information

W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181

Other recalls by Integra LifeSciences Corp. d.b.a. Integra Pain Management

  • Z-2733-2016 Class II — Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND (August 24, 2016)
  • Z-2868-2016 Class II — PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide li (August 24, 2016)
  • Z-2684-2016 Class II — INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. (August 4, 2016)
  • Z-0193-2016 Class II — Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices (September 22, 2015)
  • Z-1544-2015 Class II — Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch (March 30, 2015)
  • Z-0551-2014 Class II — Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Ac (November 26, 2013)
  • Z-0533-2014 Class II — Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 3 (October 28, 2013)
  • Z-2260-2013 Class II — Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHIT (September 4, 2013)
  • Z-1943-2012 Class III — Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, (June 7, 2012)