Events

Recall of Device Recall Neptune waste management system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments, Instruments Div..

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
    25142
  • Event Risk Class
    Class 2
  • Event Number
    Z-0524-03
  • Event Initiated Date
    2002-12-03
  • Event Date Posted
    2003-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25290
  • 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
    Apparatus, Exhaust, Surgical - Product Code FYD
  • Reason
    Cap may be cracked and fail, exposing o.R. staff to patient blood, and cause an unexpected loud noise in the o.R.
  • Action
    Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.

Device

Device Recall Neptune waste management system
  • Model / Serial
    All systems with a rover top cap assembly 711-27-001 manufactured from 1/1/01 to 12/31/01. The recalled caps can be visually distinguished because there is a flat lip where the lid connects to the unit, and the flat lip is covered by a metal retaining ring which holds the cap in place. Non-recalled units do not have a metal retaining ring, rather the caps are held in place by screws with ribs in the cap on either side of each screw.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States
  • Product Description
    Stryker brand Neptune waste management system; model 711-27-1.
  • Manufacturer
    Stryker Instruments, Instruments Div.

Manufacturer

Stryker Instruments, Instruments Div.
  • Manufacturer Address
    Stryker Instruments, Instruments Div., 4100 E. Milham, Kalamazoo MI 49001
  • Source
    USFDA