Z-0903-2014Class II
Neptune 2 Rover Ultra Waste Management System
Stryker Corp. / initiated 2013-12-30 / Terminated / root cause: design
Stryker Instruments Div. of Stryker Corporation began a recall of Neptune 2 Rover Ultra Waste Management System on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0903-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- Neptune 2 Rover Ultra Waste Management System
- Product code
- JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
- 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.
- Root cause tag
- design
- FDA 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 this recall, please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Neptune Customer Care Center 855-458-7441 or 269-389-2316 [email protected]
- Distribution
- Nationwide and Canada, Germany, Australia, New Zealand
- Product codes and lots
- Manufacturer Part Number 0702-002-000 (230V) All serial numbers
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0902-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0903-2014 | Class II | Terminated | Voluntary: Firm initiated |
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