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Recall Observatory FDA recall evidence

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

August 24, 2015

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corp
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

    reason.no_named_rule · v1.0.0

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