Recall Z-1943-2012— Integra LifeSciences Corp. d.b.a. Integra Pain Management

Name: FDA recall Z-1943-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-07

Class III · Terminated

Class III FDA medical device recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, initiated 2012-06-07, terminated 2012-08-07. It names one FDA 510(k) clearance: K945484. Product: Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.. Reason: Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components..

Recalling firm: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Classification: Class III
Status: Terminated
Initiated: 2012-06-07
Terminated: 2012-08-07
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

Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.

Reason for recall

Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.

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