Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators
Terumo is recalling six custom cardiovascular procedure kits nationwide because they contain recalled Medivators HPH700 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling six units of the Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack (P/N: 74039-02, Lot TD02). These kits were distributed nationwide, including in California, Connecticut, Florida, and Wisconsin.
The recall is necessary because the kits contain Medivators HPH700 High Performance Hemoconcentrators, which are subject to a separate recall. The hemoconcentrators are intended for use as an ultrafiltration system to remove excess fluid during or following cardiopulmonary bypass procedures.
Healthcare facilities and users should stop using these specific kits and contact Terumo Cardiovascular Systems Corp for further instructions.
The recalled product
- Product
- 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 applicatio
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 6
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: TD02
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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