Class I Recall of Certain Stryker Waste Management Systems

Personal and monetary injuries sustained due to faulty medical devices tend to be a “hot topic” here at LawInfo.com.  Therefore, I like to stay up to date with medical device recalls.  You can find a list of our “Hot Topics” directly on our homepage at LawInfo.com.

One recall that caught my eye was the Class I recall for Stryker Instruments, Neptune Rover Waste Management Systems.  According to the FDA, Class I recalls are the most serious type of recall and may even cause death.  Stryker Instruments had previously recalled these waste management systems in June of 2012, because the Instructions For Use (IFU) did not expressly warn health care providers against connecting the device in situations where passive drainage was needed.

Now, the FDA has issued a safety communication regarding the Neptune 1 Silver and Neptune 2 Ultra Waste Management Systems.  The reason for this safety communication by the FDA is to alert health care providers to only use the Neptune 1 Silver or the Neptune 2 Ultra Waste Management Systems if there are no other alternative waste management system available.  If your facility does not have an alternative waste management system for surgical waste disposal, click here for recommendations of how to mitigate the risks of using the Neptune devices.

What are these Neptune Waste Management Devices used for?

The Neptune 1 Silver and the Neptune 2 Ultra Waste Management Systems are used for disposing surgical fluid waste in operating rooms and surgical facilities.

Recalled Product Information:

• Recalling Firm: 
 Stryker Instruments
• Product Names: Neptune 2 Rover Ultra (120V), Neptune 2 Rover Ultra (230V), Neptune 1 Gold Rover (120V), Neptune 1 Gold Rover International (230V), Neptune 1 Silver Rover (120V), and Neptune 1 Bronze Rover
• Date Products were Manufactured: February 2001 through April 6, 2012
• Date Products were Distributed: March 26, 2001 through April 6, 2012
• Initial Recall Date: June 8, 2012

Additional Information:

Health care professionals and consumers, who have experienced negative reactions as a consequence of these waste management systems, may report their problems to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

What to Do if a Recalled Product Has Affected You

If you or a loved one has become injured as a result of a recalled product, you may be entitled to compensation.  It would be beneficial to speak to an attorney specializing in products liability.  Most of the attorneys here at LawInfo.com offer free initial consultations, so it would be advantageous to at least talk to an attorney about your case and get some feedback.