Events

Recall of Device Recall PHS Spinal Tray 24G Gertie Marx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp. d.b.a. Integra Pain Management.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75029
  • Event Risk Class
    Class 2
  • Event Number
    Z-2868-2016
  • Event Initiated Date
    2016-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149139
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Anesthesia conduction kit - Product Code CAZ
  • 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.
  • Action
    Consignees notified on 8/24/16 via an Urgent - Field Corrective Action letter e-mail. The letter identified the affected device and the reason for the recall. Customers were asked to review their inventory of the Spinal Tray 24 G Gertie Marx to confirm the quantity received. The attached form should be completed and returned by e-mail or fax as indicated. Once the form is received, Customer Service will place an order for the customer to receive replacement devices. Questions should be directed to Customer Service at 1-800-241-2210.

Device

Device Recall PHS Spinal Tray 24G Gertie Marx
  • Model / Serial
    Lot Number affected: W1503532
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to CA.
  • 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.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management

Manufacturer

Integra LifeSciences Corp. d.b.a. Integra Pain Management
  • Manufacturer Address
    Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 W 2400 S Ste 1050, Salt Lake City UT 84119-1135
  • Manufacturer Parent Company (2017)
    Integra LifeSciences Holdings Corporation
  • Source
    USFDA