ClearanceBrief
Recall Z-0524-03 ยท FYD Apparatus, Exhaust, Surgical

Stryker Instruments, Instruments Div.

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

DateFeb 1, 2003 (initiated Dec 3, 2002)
StatusTerminated
ReasonCap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
Root causeOther
ActionEach 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.
Quantity370
DistributionUnited States
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K012991NEPTUNE WASTE MANAGEMENT STSTEM
Stryker Instruments, Nov 29, 2001
K990037NEPTUNE WASTE MANAGEMENT SYSTEM
American Immuno Tech, Aug 24, 1999