Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators
Terumo is recalling 5 Custom Cardiovascular Procedure Kits 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 indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling five Custom Cardiovascular Procedure Kit Tubing Packs (P/N: 66041-1, Lot Number: TE06). 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 medical devices intended for use during cardiopulmonary bypass procedures to remove excess fluid. The recall covers nationwide distribution, including California, Connecticut, Florida, and Wisconsin.
Healthcare facilities and 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 Tubing Pack P/N: 66041-1 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 t
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Hazard
- Affected units
- 5
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: TE06
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.
See all 7 products in this recall →Related recalls
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