Terumo Custom Cardioplegia Delivery Set Recalled for Luer Connector Defect
Terumo is recalling Custom Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.
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 involves a medical device defect that poses a risk of harm (air introduction) to patients, but the source text does not report any specific 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 the Terumo Custom Cardioplegia Delivery Set, specifically Catalog Numbers 165720 and 6375. These devices are designed to deliver blood or solution to patients undergoing cardiopulmonary bypass surgery. The recall covers units distributed in the United States, Canada, Brazil, Hong Kong, Korea, and Thailand.
The recall is due to a defect in the female luer connector that can compromise the seal. This compromised seal has the potential to introduce air into the tubing line. The affected lots were manufactured between March 15, 2010, and December 13, 2010.
Healthcare facilities and distributors should stop using the affected devices and contact Terumo Cardiovascular Systems Corp for instructions on how to return or dispose of the products.
The recalled product
- Product
- Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solu
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Category
- Medical Device — Cardiovascular
- Hazard
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 (10)
- Catalog Number: 165720 Lot Numbers: MDI5
- MD15B
- MD22
- ME19
- MP13. Manufacturing dates March 15
- 20 I 0 through December 13
- 20 I 0. Catalog Number: 6375 Lot Numbers: MD15
- MPI3 Manufacturing dates March 15
- 2010 through December 13
- 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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