Device product
Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 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
Z-2787-2015
Product summary
- Event
- Event 72010
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 kits
- Official record key
device-enforcement:Z-2787-2015
Official wording
Reason: Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
Code information: Lot Numbers: TD02,TD02A, TD23, TD23A
Distribution pattern: Nationwide Distribution including CA, CT , FL , WI.
Derived failure modes
-
Unknown
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators