Terumo Cardiovascular Systems Corp recalls Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits…

Recall date

August 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2792-2015

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corp

Sold / distributed

Nationwide Distribution including CA, CT , FL , WI.

Why it was recalled

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed