Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect
Terumo is recalling 777 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 used during surgery where a defect could introduce air into the line, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 777 units of the Terumo Cardioplegia Delivery Set, Item Number 16130. These sets are indicated for the delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The affected lots are MN08, MNI5, MM11, MM18, and MM25, with manufacturing dates ranging from October 11, 2010, through November 15, 2010.
The recall is due to a defect in the luer connector that can compromise the seal on the female side of the connector. This compromised seal can introduce air into the tubing line. The affected products were distributed nationwide in the United States and in Canada, Brazil, Hong Kong, Korea, and Thailand.
Healthcare facilities and distributors should stop using the affected products and contact Terumo Cardiovascular Systems Corp for instructions on return or replacement. Patients who have received these sets should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Hazard
- Affected units
- 777
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 (7)
- Lot Numbers: MN08
- MNI5
- MM11
- MM18
- MM25. Manufacturing dates October 1I
- 2010 through Novemberl5
- 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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