Stryker Internal Waste Management System Product Recall
Stryker, a medical device company, recently issued a Class 1 recall of its entire Neptune Rover Waste Management System. Reports say that at least one fatality has been linked to a passive drainage tube connected to the Neptune System, due to severe tissue damage caused by the product.
Products included in this recall are listed under the following names, dates, and product numbers.
|
Product Name |
Catalog Number |
Manufacture Dates |
Distribution Dates |
IFU Part Number |
| Neptune 1 Gold Rover | 0700-001-000 | 1/11/01 – 12/23/09 | 3/26/01 – 1/30/10 | 0700-001-700 |
| Neptune 1 Gold Rover – International | 0700-002-000 | 9/15/05 | 10/3/05 – 10/3/05 | 0700-002-707 |
| Neptune 1 Silver Rover | 0700-003-000 | 1/31/02 – 9/3/09 | 5/31/02 – 11/19/09 | 0700-001-700 |
| Neptune Bronze | 0700-007-000 | 3/22/04 – 2/22/12 | 3/31/04 – 6/27/12 | 0700-007-720 |
| Neptune 2 Rover ltra (120 V) | 0702-001-000 | 12/3/07 – 8/1/12 | 12/31/07 – 8/7/12 | 0702-002-700 |
| Neptune 2 Rover Ultra (230 V) | 0702-002-000 | 10/9/08 – 6/18/12 | 3/5/09 – 7/26/12 | 0702-002-700 |
The company issued letters to all medical professionals and customers via overnight mail, warning that some of these products have not received 510(K) clearance, and have been marketed without specific FDA approval.
Furthermore, Stryker did not officially make a statement that these products were not to be used with a passive drainage tube, leading to misuse of the product. Individuals recently involved in surgery should immediately contact their healthcare provider to view the risks and the potential repercussions from surgeons’ use of this product.
If you or a loved on have been injured or you’ve lost a loved one due to the negligence of another party you should seek legal assistance. Our Toledo, Ohio wrongful death lawyers are here to help you through every part of your case. Call our toll-free number at 800.637.8170 to review your case with one of our attorneys.
