Recalls / —
—#124913
Product
Neptune 2 Rover Ultra Waste Management System
- FDA product code
- JCX — Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K132671
- Affected lot / code info
- Manufacturer Part Number 0702-002-000 (230V) All serial numbers
Why it was recalled
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 (FDA determination)
Device Design
Action the firm took
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
Recalling firm
- Firm
- Stryker Instruments Div. of Stryker Corporation
- Address
- 4100 E Milham Ave, Portage, Michigan 49002-9704
Distribution
- Distribution pattern
- Nationwide and Canada, Germany, Australia, New Zealand
Timeline
- Recall initiated
- 2013-12-30
- Posted by FDA
- 2014-01-31
- Terminated
- 2016-01-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #124913. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.