Recalls / —

—#35627

Product

Stryker brand Neptune waste management system, Neptune Rover, 15 amp plug; model 0700-003-000.

FDA product code

FYD — Apparatus, Exhaust, Surgical

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

All units with an Interpower brand AC power plug, which includes serial numbers 0203177 through 0406301403.

Why it was recalled

The grounding pin may break inside of the electrical plug, resulting in a shock hazard.

Root cause (FDA determination)

Other

Action the firm took

Hospital customers will be sent a recall notice dated 11/09/04, new plugs for installation on their units, and instructions for installation.

Recalling firm

Firm

Stryker Instruments Div. of Stryker Corporation

Address

4100 E. Milham, Kalamazoo, Michigan 49001

Distribution

Distribution pattern

United States and Canada.

Timeline

Recall initiated

2004-10-12

Posted by FDA

2004-11-04

Terminated

2005-03-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35627. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.