Home / Recalls / Integra LifeSciences Corp. d.b.a. Integra Pain Management / Z-0533-2014

Z-0533-2014 Class II Terminated

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

FDA device recall Z-0533-2014 was initiated by Integra LifeSciences Corp. d.b.a. Integra Pain Management on October 28, 2013 and is designated Class II. Reason for recall: Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicati… The recall status is terminated (terminated January 29, 2014). Affected quantity: 359,250.

Recall Details

Product Type
Devices
Report Date
December 25, 2013
Initiation Date
October 28, 2013
Termination Date
January 29, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
359,250

Product Description

Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.

Reason for Recall

Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.

Distribution Pattern

USA Nationwide Distribution and one foreign consignee in Mursalat.

Code Information

Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,3404131,3404269,3404293,3404417,3404468,3404578,3503559,CUS025,CUS1121-01,CUS1164-02,CUS1202-04,CUS1298-03,CUS1376,CUS1376,CUS1400-01,CUS1406-03,CUS1415-04,CUS1568-01,CUS1664-01,CUS1696,CUS1723,CUS1760,CUS1773-01,CUS1797,CUS279-02,CUS416,CUS597,CUS628-02,CUS755,PISLL7,RSM394,RSM395,SS1246,SS2036-01,

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-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-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)

FDA data resources