Terumo Cardiovascular Procedure Kits Recalled Due to Uncleared Safety Valve
Terumo is recalling 24,227 Custom Cardiovascular Procedure Kits because the Overpressure Safety Valve used in the arterial line was not cleared for that specific use.
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. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving medical devices where the probability of serious adverse health consequences is remote but not zero.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 24,227 units of Custom Cardiovascular Procedure Kits. These kits contain an Overpressure Safety Valve, model LN130B, located in the Arterial Recirculation Line. The recall is being conducted because this specific valve was not cleared by the FDA with an indication for use on the arterial side of the extracorporeal bypass circuit.
The affected products were distributed nationwide and in Canada. The recall is classified as Class II by the FDA, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and distributors should stop using the affected kits and contact Terumo Cardiovascular Systems Corporation for instructions on how to return the products. Patients who have already received these kits should consult their healthcare provider if they have concerns regarding the procedure.
The recalled product
- Product
- Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 24,227
Distribution
Distributed nationwide across the United States.
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