FDA Device

Stryker brand Neptune waste management system; model 711-27-1.

Hazard

Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.

What You Should Do

Remedy

Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.

Products

Stryker brand Neptune waste management system; model 711-27-1.
Brand
Stryker Instruments, Instruments Div.
UPC
All systems with a rover top cap assembly 711-27-001 manufactured from 1/1/01 to 12/31/01. The recalled caps can be visually distinguished because there is a flat lip where the lid connects to the unit, and the flat lip is covered by a metal retaining ring which holds the cap in place. Non-recalled units do not have a metal retaining ring, rather the caps are held in place by screws with ribs in the cap on either side of each screw.

Units Affected

370