Recall Z-2868-2016— Integra LifeSciences Corp. d.b.a. Integra Pain Management

Name: FDA recall Z-2868-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-24

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, initiated 2016-08-24, terminated 2016-12-19. It names one FDA 510(k) clearance: K943319. Product: PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. 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 anesthetics.. Reason: Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer..

Recalling firm: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Terminated: 2016-12-19
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K943319 — GERTIE MARX EPI-SPINAL TRAYSpinal Specialties, Inc.·cleared 1995-06-30

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

PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. 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 anesthetics.

Reason for recall

Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.

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