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

Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack recalled

Terumo Cardiovascular Systems is recalling Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric 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: TD02

Quantity recalled6 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-2789-2015
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 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

Where it was distributed

Nationwide Distribution including CA, CT , FL , WI.

Nationwide California Connecticut Florida Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Numbers: TD02

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

Other products in this recall event

6 other products · FDA event 72010

This product is part of a recall event; the main page for the event is Terumo Custom Cardiovascular Procedure Kit Tubing Pack recalled.

Reported	Class	Recall	Company	Reason	Where
30 Sep 2015	CLASS II	Terumo Custom Cardiovascular Procedure Kit Tubing Pack recalled	Terumo Cardiovascular Systems	Other	Nationwide
30 Sep 2015	CLASS II	Terumo Custom Cardiovascular Procedure Kit X-Coated recalled	Terumo Cardiovascular Systems	Other	Nationwide
30 Sep 2015	CLASS II	Terumo Custom Cardiovascular Procedure Kit X-Coated recalled	Terumo Cardiovascular Systems	Other	Nationwide
30 Sep 2015	CLASS II	Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack recalled	Terumo Cardiovascular Systems	Other	Nationwide
30 Sep 2015	CLASS II	Terumo Custom Cardiovascular Procedure Kit X-Coated recalled	Terumo Cardiovascular Systems	Other	Nationwide
30 Sep 2015	CLASS II	Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak recalled	Terumo Cardiovascular Systems	Other	Nationwide

More recalls from Terumo Cardiovascular Systems

All 222

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Device	CLASS II	CDI OneView System BPM Probe recalled by Terumo Cardiovascular Systems	Terumo Cardiovascular Systems	Labeling Errors	Nationwide
9 Apr 2025Device	CLASS II	Terumo CDI OneView Monitoring System Hematocrit / Oxygen recalled	Terumo Cardiovascular Systems	Device Malfunction	6 states
10 Apr 2024Device	CLASS II	Cardiovascular Procedure Kits that include High Crack Check recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
12 Apr 2023Device	CLASS II	Capiox RX15 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
12 Apr 2023Device	CLASS II	Capiox FX25 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide