Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Dockin

FDA device recall Z-2524-2015 · posted 2015-09-01 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

Reason for recall

The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is waste fluid and/or fresh water dispensed from the Neptune 2 Rover at the incorrect time.

Action taken

Stryker sent an Urgent Medical Device Notification letter dated August 4, 2015 via FedEx to all domestic customers, and all international cutsomers and sales reperesentatives were notified via e-mail. The letter identified the affected product, problem and actions to be taken. Customers are asked to complete the response form and return it to Stryker whether they have affected devices or not. Fax the completed, signed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com. For questions regarding this recall, contact Stryker Instruments at 269-389-2921.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FYD

Quantity affected

524, 237 of these are non-conforming

Distribution

Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,

Date initiated

2015-07-20

Date posted

2015-09-01

Date terminated

2016-11-07

Location

Portage, MI

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