Recall Z-0533-2014— Integra LifeSciences Corp. d.b.a. Integra Pain Management

Name: FDA recall Z-0533-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-28

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, initiated 2013-10-28, terminated 2014-01-29. It names one FDA 510(k) clearance: K945484. Product: 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: 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..

Recalling firm: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Classification: Class II
Status: Terminated
Initiated: 2013-10-28
Terminated: 2014-01-29
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K945484 — PIDURAL STEROID SYSTEMProfessional Medical Device Consultants·cleared 1995-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.