Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrator Component
Terumo is recalling 15 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 High Performance Hemoconcentrators.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 15 units of Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack (P/N: 74077-01). The recall is necessary because these kits contain Medivators HPH700 High Performance Hemoconcentrators, which are subject to a separate recall. The kits are customized for specific purchasers and include various legally marketed medical devices.
The affected products were distributed nationwide, including in California, Connecticut, Florida, and Wisconsin. The specific lot number for the recalled kits is TD23. The HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during or following cardiopulmonary bypass procedures.
Healthcare facilities and purchasers should stop using the affected kits and contact Terumo Cardiovascular Systems Corp for instructions on returning the products. This recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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 applicatio
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 15
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 (1)
- Lot Numbers: TD23
Distribution
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.
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