[UFDAmedwatchPDATE 03/15/2012] In the past 6 months, the FDA has become aware of additional death and injury reports related to these recalled devices. The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied and were associated with users of the device who had not been properly trained on how to use the device.

Stryker and the FDA are particularly concerned about these cases, since a requirement for continuing to use these devices under the Certificate of Medical Neccesity is to ensure that all users are adequately trained and have implemented the use of the Pre-use Checklist.

Stryker issued updated recall notifications dated Feb. 20, 2013 for the Neptune 1 Silver and the Neptune 2 Ultra reminding customers of the steps they need to take to continue using these devices. Health care facilities that must use these devices need to ensure the following steps are completed, as stated in their Certificate of Medical Necessity:

  • Ensure ALL USERS of the Neptune 1 Silver and Neptune 2 Ultra are properly trained before the use of the device and aware of the risks associated with the device.
  • Implement the Neptune Pre-use Checklist within your facility. This checklist must be completed BEFORE EVERY PROCEDURE for which a Neptune 1 Silver and/or Neptune 2 Ultra device is used.
  • Identify a training facilitator or device champion for each facility/hospital who will ensure the Neptune Pre-use Checklist is implemented consistently with your facility’s standard protocol and in a way that makes sense for your facility to document the checklist was completed.
  • Prior to using the device, health care providers should follow the recommendations listed in the updated safety communication to mitigate the risks of using these devices.

To read the MedWatch safety alert, including links to the FDA Safety Communication, Stryker Urgent Medical Device Recall Notification, and Neptune Pre-use Checklist, click here.