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Terminated

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

FDA Recall Z-0524-03 · Posted 2003-02-01

Recalling FirmStryker Instruments, Instruments Div.
Recall StatusTerminated
Product CodeFYD
Date Initiated2002-12-03
Date Terminated2003-07-07
Product Quantity370

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.

Firm 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.

Root Cause

Other

Distribution Pattern

United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012991NEPTUNE WASTE MANAGEMENT STSTEMStryker Instruments · 2001-11-29K990037NEPTUNE WASTE MANAGEMENT SYSTEMAmerican Immuno Tech · 1999-08-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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