Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack… — Class II medical device recall Z-2788-2015
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-2788-2015 |
|---|---|
| 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 | 30 kits |
| Lot numbers | TD02, TD16 |
Product
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 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-2788-2015. 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.