Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2868-2016

August 24, 2016

Class II

Product summary

Firm
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Event
Event 75029
Status
Terminated
Classification
Class II
Quantity
320 packages
Official record key
device-enforcement:Z-2868-2016

Official wording

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.

Code information: Lot Number affected: W1503532

Distribution pattern: Distributed to CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.