Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect
Terumo is recalling 17 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, and the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 17 units of Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack (P/N: 75529). 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 intended for use during cardiopulmonary bypass procedures. The distribution was nationwide, including California, Connecticut, Florida, and Wisconsin. The specific lot number for the recalled kits is TC23.
Healthcare facilities and purchasers should stop using these kits and contact Terumo Cardiovascular Systems Corp for instructions on return or replacement.
The recalled product
- Product
- Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 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…
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Hazard
- Affected units
- 17
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 Number: TC23
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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