Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Recalled by Terumo Cardiovascular Systems Corp Due to Custom Cardiovascular Procedure Kits contain recalled component Medivators...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corp directly.
Affected Products
Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 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
Quantity: 6 kits
Why Was This Recalled?
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Systems Corp has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report