Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1… — Class II medical device recall Z-2786-2015

Terminated recall by Terumo Cardiovascular Systems Corp, reported 2015-09-30, distributed nationwide. Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcent

Recall number	`Z-2786-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Terumo Cardiovascular Systems Corp, Ashland, MA, United States
Recall initiated	2015-08-24
Classified	2015-09-18
Reported by FDA	2015-09-30
Terminated	2016-02-05
Distributed	Nationwide (US)
Quantity	5 kits
Lot numbers	`TE06`

Product

Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2786-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.