Terumo Cardiovascular Systems Corp: Medical Device Recall in 2015 - (Recall #: Z-2788-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 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

Product Classification:

Class II

Date Initiated: August 24, 2015

Date Posted: September 30, 2015

Recall Number: Z-2788-2015

Event ID: 72010

Reason for Recall:

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

Status: Terminated

Product Quantity: 30 kits

Code Information:

Lot Numbers: TD02, TD16

Distribution Pattern:

Nationwide Distribution including CA, CT , FL , WI.

Voluntary or Mandated:

Voluntary: Firm initiated