March 28, 2013
On Friday, March 15, the FDA released a Safety Communication about Neptune 1 Silver & Neptune 2 Ultra. This communication provides additional information on the Urgent Medical Device Recall Notification, sent to customers on February 20. Stryker is providing additional information and clarification around two points:
1. The FDA states, “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.”
In order to comply with this Pre-Use Checklist requirement stated by the FDA, you must be able to produce the following for any procedure utilizing Neptune 1 Silver or Neptune 2:
- Evidence the entire Pre-Use Checklist was completed before each procedure
- Evidence of who was in the operating room
- Anyone who could interact with Neptune 1 Silver or Neptune 2 while being used for patient care
- Anyone involved in providing patient care where a Neptune 1 Silver or Neptune 2 is present
- Verification of training for the parties listed above prior to each procedure
Evidence can be written or electronic documentation in order to allow your facility to implement the Pre-Use Checklist consistent with your facility’s standard protocol.
2. The FDA states, “If you plan to continue using the Neptune 1 Silver and/or the Neptune 2 Ultra devices, you must update your Certificate of Medical Necessity and send it back to Stryker Instruments at firstname.lastname@example.org
or fax 866.521.2762 by March 25, 2013. If a Certificate of Medical Necessity is not received by this date, Stryker will not be able to provide any disposable accessories, replacement parts or provide service for your device(s).”Facilities should contact Stryker directly if they need an extension of the March 25, 2013 deadline to implement the updated Certificate of Medical Necessity.
To update your Certificate of Medical Necessity you must:
- Complete all actions in the Urgent Medical Device Recall Notification, sent February 20, 2013
- Complete and submit your Business Reply Form to email@example.com or fax to 866.521.2762
- It is not required to submit a new Certificate of Medical Necessity. By submitting your Business Reply Form your Certificate of Medical Necessity will be updated
- Your Certificate of Medical Necessity will be updated if you requested an extension upon receipt of the Business Reply Form on or before April 25
If you have any additional questions, contact the Neptune Customer Care Center at firstname.lastname@example.org or 855.458.7441. Stryker has a web site to address customer concerns that provides training materials, including webinars and a training assessment, for facilities using the Neptune 1 Silver and Neptune 2 Ultra devices under the Certificate of Medical Necessity program.
In addition, read the MedWatch safety alert, which includes links to the FDA Safety Communication, Stryker Urgent Medical Device Recall Notification and Neptune Pre-use Checklist.
Recall Checklists for:
Neptune Gold and Neptune Bronze
Neptune 1 Silver