CLASS II Device recall · Reported 30 Sep 2015 · FDA Enforcement Report

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack recalled

Terumo Cardiovascular Systems is recalling Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack, distributed nationwide in the US. The recall was initiated on 24 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: TD23

Quantity recalled15 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2790-2015
FDA event ID: 72010
Recalling firm: Terumo Cardiovascular Systems, Ashland, MA
Classification: Class II
Status: Terminated
Recall initiated: 24 Aug 2015
FDA classified: 18 Sep 2015
Reported: 30 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

24 Aug 2015	Recall initiated by company
18 Sep 2015	Classified by FDA	+25 days
30 Sep 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Product as listed by the FDA

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 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

Where it was distributed

Nationwide Distribution including CA, CT , FL , WI.

Nationwide California Connecticut Florida Wisconsin

Questions about this recall

Is Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack recalled?

Yes. Terumo Cardiovascular Systems recalled Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack on 24 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-2790-2015.

Why was it recalled?

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Which lots are affected?

Lot Numbers: TD23

Where was it sold?

Nationwide Distribution including CA, CT , FL , WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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