Z-2790-2015 Class II Terminated
FDA device recall Z-2790-2015 was initiated by Terumo Cardiovascular Systems Corp on August 24, 2015 and is designated Class II. Reason for recall: Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators The recall status is terminated (terminated February 5, 2016). Affected quantity: 15 kits.
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
- 15 kits
Product Description
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 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: TD23