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Terumo Cardiovascular Systems Corp recalls Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manu
Recalled September 30, 2015 · FDA recall Z-2787-2015 · Terumo Cardiovascular Systems
Hazard
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators · FDA Class II
Units
32 kits
Sold at
Nationwide Distribution including CA, CT , FL , WI.
Description
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
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
Manufacturer(s)
Terumo Cardiovascular Systems Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →