Neptune Rover Waste Management System recall
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of…
Why was Neptune Rover Waste Management System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Neptune 2 Rover Ultra (120 V) 0702-001-000 Neptune 2 Rover Ultra (230 V) 0702-002-000 associated IFU 0702-002-700
- Product
- Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 10,394 domestic, 276 international
- Distribution
- Worldwide Distribution -- USA (nationwide) and country of: Canada. .
- Recall date
- August 22, 2012
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)