Z-2792-2015Class II

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular...

Name: Z-2792-2015 Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular...
Creator: Terumo Cardiovascular Systems Corp
Published: 2015-08-24
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2015-08-24 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the... on 2015-08-24. FDA classified it as Class II and gives the reason as "Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2792-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-24
Posted: 2015-09-18
Terminated: 2016-02-05
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 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
Product code: N/A
Reason for recall: Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo CVS issued an Urgent Medical Device Recall Notice dated August 24, 2015, to consignees via express mail. The letter advised users to immediately quarantine affected Cardiovascular Procedure Kits and stop using the Hemocor HPH700 Hemoconcentrator within the kit. Replacement sterile, stand-alone Hemocor HPH700 Hemoconcentrators will accompany the letter so that users may replace the affected emoconcentrators at the point of use. The option of replacing the hemoconcentrator at the point of use is offered to facilitate imminently scheduled cardiopulmonary bypass procedures. Users are requested to return the unused hemoconcentrators to Terumo CVS. Alternatively, users may return the entire Cardiovascular Procedure Kit to Terumo CVS for replacement. Customers with questions were instructed to call 763-553-3348.
Quantity in commerce: 17 kits
Distribution: Nationwide Distribution including CA, CT , FL , WI.
Product codes and lots: Lot Number: TC23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2792-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2786-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-18
Z-2787-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-18
Z-2788-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-18
Z-2789-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-18
Z-2790-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-18
Z-2791-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-18
Z-2792-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-18

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)