Neptune recall?

Discussion in 'Stryker' started by Anonymous, Mar 16, 2013 at 7:10 AM.

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  1. Anonymous

    Anonymous Guest

    I heard it was bc someone hooked a chest tube up to it and it sucked the patient inside out. Really.
     

  2. Anonymous

    Anonymous Guest

    Yep
     
  3. Anonymous

    Anonymous Guest

    You really backed that up with intelligent points, I'm sure you know what your talking about.
     
  4. Anonymous

    Anonymous Guest

    Zimmer guys are not shrimp dicks. More like Shamu dicks. Bow to your new master!
     
  5. Anonymous

    Anonymous Guest

    On September 25, 2012, Stryker issued an urgent notice that it was expanding its recall of Neptune Waste Management Systems to include newer models that were never properly approved by the U.S. Food & Drug Administration (FDA). In all, this recall affects the following products:

    Neptune 1 Gold Rover (manufactured between 1/11/01 – 12/23/09 and distributed between 3/26/01 – 1/30/10);
    Neptune 1 Gold Rover - International (manufactured on 9/15/05 and distributed on 10/3/05);
    Neptune 1 Silver Rover (manufactured between 1/31/02 – 9/3/09 and distributed between 5/31/02 – 11/19/09);
    Neptune Bronze (manufactured between 3/22/04 – 2/22/12 and distributed between 3/31/04 – 6/27/12);
    Neptune 2 Rover Ultra (120 V) (manufactured between 12/3/07 – 8/1/12 and distributed between 12/31/07 – 8/7/12);
    Neptune 2 Rover Ultra (230 V) (manufactured between 10/9/08 – 6/18/12 and distributed between 3/5/09 – 7/26/12).
     
  6. Anonymous

    Anonymous Guest

    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 Neptune 2 (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.
     
  7. Anonymous

    Anonymous Guest

    Why would any hospital sign that and continue to use these machines???? Are they essentially assuming all liability if this non FDA cleared device has any issue at all including more patients being injured or killed? Also by signing this are hospitals giving up there ability to send the machines back to Stryker and demand a full refund or is Stryker not offering that option?
     
  8. Anonymous

    Anonymous Guest

    Because Stryker has bundled this machine into many different divisions. The hospital sends back the Neptunes for a refund. Stryker counters with, "Ok that's fine, we will now raise your joint, trauma, power, bed, etc. pricing."
     
  9. Anonymous

    Anonymous Guest

    Balls in the hospitals court. Stryker lied on the contracts where FDA approval is needed. Hospital can rip it up, and ask for better discount or to open up hospital to other vendors. I literally have seen Zimmer get into places where old contracts say they couldn't.
     
  10. Anonymous

    Anonymous Guest

    Bad call for Stryker. Zimmer picked up that company at a good time. Adios Neptune's.
     
  11. anonymous

    anonymous Guest

    I don't care about FDA Approval, like anyone they can be bought! All I know is we had NO problems with Neptune, and then overnight we had zimmer junk forced down our throats, and now I have to CONSANTLY call for repair, I just had the evacuator replaced for the 6th time At LEAST, the last one was 1 week ago. My staff CONSTANTLY complain, and the smell! this was a quick make money scandal that ma dirty crooks made money and I bet that it of course involved FDA being bought. How else did we get all these Dornochs OVERNIGHT. we had 3 whole units swapped out and the tech had to redrill holes for the IV pole cause they did not line up, we had to buy charcoal filters cause of the smell, and you have to disassemble half the unit to access it. there is NO easy access panel to get to it. To evac the unit you have to open to Abient air, and ITS SUPPOSE TO BE CLEAN?
    come on now
     
  12. anonymous

    anonymous Guest

    Way to bring back a dead thread dip shit.