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 Div. of Stryker Corporation.

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
    61747
  • Event Risk Class
    Class 1
  • Event Number
    Z-2062-2012
  • Event Initiated Date
    2012-06-08
  • Event Date Posted
    2012-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109233
  • 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
    Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the neptune 2, including an event in which one customer connected the neptune 2 system to a passive chest drainage tube post operatively, resulting in a fatality. the current ifu did not specifically warn against connecting all neptune waste management devices, which is a high vacuum/high flow device, to a passive drainage tube. june 12, 2012, customers were instructed to review the revised ifu, distribute to affected departments, and educate users of the neptune on this warning. warning labels, which are pending distribution, are required on all neptune devices. further investigation found the neptune 1 silver, neptune 2 ultra (120v) and neptune 2 ultra (230v) lacked fda 510(k) clearance and therefore are not legally marketed without determination of their safety and effectiveness. fda advises neptune 1 silver, neptune 2 ultra (120v) and neptune 2 ultra (230v) not be used. however, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. if customers choose to continue use of the neptune silver, neptune 2 ultra (120v) or neptune 2 (230v), they must complete a certificate of medical necessity and return it to stryker by october 12, 2012.
  • Action
    On June 5, 2012, Stryker notified customers that it was recalling the IFUs for the above products. The current IFU did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Customers must confirm with Stryker via business reply form that they have completed these actions. Customers who have the Neptune 1 Gold, Neptune 1 Gold International or Neptune 2 Bronze will receive a follow up mailing containing warning labels for the device and instructions detailing how to apply them. Customers may continue to use the Neptune 1 Gold, Neptune 1 Gold International, and the Neptune 1 Bronze without any further actions. On September 18, 2012, Stryker notified customers via letter delivered by FedEx overnight delivery that it is expanding the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance. FDA is therefore unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System (510(k) K012992). As such, Stryker has ceased distribution of the Neptune Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) devices until FDA clears these devices. At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Nept

Device

Device Recall Neptune Waste Management System
  • Model / Serial
    120V Gold part numbers 0700-001-000 IFU 0700-001-700 230 V Gold 0700-002- 000, IFU 0700-002-707  Neptune 1 Gold Rover 0700-001-000 1/11/01  12/23/09 3/26/01  1/30/10 0700-001-700 Neptune 1 Gold Rover - International 0700-002-000 9/15/05 10/3/05  10/3/05 0700-002-707
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and country of: Canada. .
  • Product Description
    Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) || Instructions For Use 0700-001-700, 0700-002-707 || Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA