Home / Recalls / Integra LifeSciences Corp. d.b.a. Integra Pain Management / Z-1544-2015

Z-1544-2015 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
May 6, 2015
Initiation Date
March 30, 2015
Termination Date
June 24, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
90 Tuohy needles (9 cases of 10 each)

Product Description

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.

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 Pattern

Nationwide Distribution.

Code Information

Lot No. W1412086, Exp DEC-2017.

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

  • Z-2868-2016 Class II — PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide li (August 24, 2016)
  • Z-2733-2016 Class II — Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND (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-2056-2015 Class II — Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inc (May 1, 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)