Z-2788-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2015
- Initiation Date
- August 24, 2015
- Termination Date
- February 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 kits
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
Reason for Recall
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
Distribution Pattern
Nationwide Distribution including CA, CT , FL , WI.
Code Information
Lot Numbers: TD02, TD16