Recall Z-2791-2015— Terumo Cardiovascular Systems Corp

Class II FDA medical device recall by Terumo Cardiovascular Systems Corp, initiated 2015-08-24, terminated 2016-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 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. Reason: Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators.

Recalling firm

Terumo Cardiovascular Systems Corp

Classification

Class II

Status

Terminated

Initiated

2015-08-24

Terminated

2016-02-05

Firm location

Ashland, MA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.