Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0524-03

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

Stryker Corp. / initiated 2002-12-03 / Terminated

Stryker Instruments, Instruments Div. began a recall of Stryker brand Neptune waste management system; model 711-27-1 on . The reason FDA records is "Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0524-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Corp.
Product
Stryker brand Neptune waste management system; model 711-27-1.
Product code
FYD Apparatus, Exhaust, Surgical
Reason for recall
Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
FDA root cause
Other
Action
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.
Quantity in commerce
370
Distribution
United States
Product codes and lots
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.