The Recall Desk
SevereFDA (Devices)·Z-2788-2015·Announced 2015-09-30

Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

Terumo is recalling 30 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 Hemoconcentrators.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant medical devices.

Plain-English summary

Terumo Cardiovascular Systems Corp is recalling 30 units of Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE (P/N: 7928-03). The recall is necessary because these kits contain Medivators HPH700 High Performance Hemoconcentrators, which are subject to a separate recall.

The affected kits are customized for specific purchasers and are distributed nationwide, including in California, Connecticut, Florida, and Wisconsin. The specific lot numbers involved are TD02 and TD16.

The FDA has classified this recall as Class II. Users should stop using the affected kits and contact Terumo Cardiovascular Systems Corp for instructions on return or replacement.

The recalled product

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 a
Manufacturer
Terumo Cardiovascular Systems Corp
Category
Medical Device — Cardiovascular
Hazard
Affected units
30

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Numbers: TD02
  • TD16

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Terumo Cardiovascular Systems Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corp

See all →

Same hazard · component defect

See all →