Recall Z-0903-2014
Stryker Instruments Div. of Stryker Corporation · initiated December 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Neptune 2 Rover Ultra Waste Management System
Codes / lots: Manufacturer Part Number 0702-002-000 (230V) All serial numbers
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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
Details
- Recall number
- Z-0903-2014
- Initiated
- December 30, 2013
- Posted by FDA
- January 31, 2014
- Terminated
- January 12, 2016
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Distribution
- Nationwide and Canada, Germany, Australia, New Zealand
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0902-2014 Class II | Neptune 2 Rover Ultra Waste Management System.The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the… | 12/30/2013Terminated |