Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect
Terumo is recalling specific 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
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 recall is classified as FDA Class II and involves a medical device defect that can introduce air into a patient's blood supply during surgery, posing a significant risk of serious injury.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling specific units of the Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass. The affected item numbers are 5852 and 16010. The recall involves 596 units of item number 5852 and 876 units of item number 16010.
The recall is due to a defect in the female luer connector. This defect can compromise the seal on the female side of the connector, which may introduce air into the tubing line. The product is a Cardioplegia Delivery System designed to deliver blood or solution to patients undergoing cardiopulmonary bypass surgery at a 4:1 ratio.
The affected lots were manufactured between May 24, 2010, and December 7, 2010. The products were distributed worldwide, including the United States, Canada, Brazil, Hong Kong, Korea, and Thailand. Healthcare facilities and users should stop using the affected units and contact Terumo Cardiovascular Systems Corp for further instructions.
The recalled product
- Product
- Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set i
- 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)
- Item Number: 58520-Lot Numbers: MF24
- MM11
- MN01. Manufacturing dates May 24
- 20 I 0 through November I
- 2010 Item Number: 1610-Lot Numbers: MM11
- MN08
- MNI5
- MN29 MP07. Manufacturing dates October 11
- 20 I 0 through December 7
- 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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