Terumo Custom Cardioplegia Delivery Sets Recalled for Luer Connector Seal Defect
Terumo is recalling 24 units of Custom Cardioplegia Delivery Sets because a luer connector defect may compromise the seal and introduce air into the line.
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 involves a medical device with a defect that can introduce air into a line, posing a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 24 units of Custom Cardioplegia Delivery Sets (Catalog Code: 204880, Lot Number: MN08). The recall was initiated because a defect in the luer connector can compromise the seal on the female side of the connector. This compromised seal can introduce air into the table line.
The affected products were distributed worldwide, including the United States (nationwide), Canada, Brazil, Hong Kong, Korea, and Thailand. The manufacturing date for the affected lot is November 8, 2010.
Healthcare facilities and consumers should stop using the affected products immediately and contact Terumo Cardiovascular Systems Corp for further instructions on replacement or return.
The recalled product
- Product
- Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Hazard
- Affected units
- 24
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 (2)
- Lot Numbers: MN08 Manufacturing Date November 8
- 20 I 0.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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