Recall Z-0902-2014 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Stryker Instruments Div. of Stryker Corporation
Neptune 2 Rover Ultra Waste Management System.
| Date | Jan 31, 2014 (initiated Dec 30, 2013) |
| Status | Terminated |
| Reason | The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. |
| Root cause | Device Design |
| Action | On 12/30/13, Stryker sent an URGENT MEDICAL DEVICE UPDATE notification to consignees including government accounts and Sales Representatives, Stryker Canada and 3 in-house accounts and 1 account for lost rovers. Domestic and government consignees were sent the notification by mail FedEx overnight, and Sales Representatives and Stryker Canada were sent the notification by email. Notification described the affected product, instructions for the consignees, and upgrade information. Stryker also stated that a training kit and in-servicing will be provided to consignees. For questions regarding |
| Distribution | Nationwide and Canada, Germany, Australia, New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132671 | STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM Stryker Corporation, Dec 20, 2013 |