FDA Device

Neptune 2 Rover Ultra Waste Management System.

Hazard

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.

What You Should Do

Remedy

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 this recall, please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Neptune Customer Care Center 855-458-7441 or 269-389-2316 strykerinstrumentsrecalls@stryker.com

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Products

Neptune 2 Rover Ultra Waste Management System.
Brand
Stryker Instruments Div. of Stryker Corporation
UPC
Manufacturer Part Number 0702-001-000 (120V) All serial numbers

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