Terumo Cardioplegia Delivery Set Line Recalled for Luer Connector Defect
Terumo is recalling 165 units of a cardioplegia delivery set line because a luer connector defect can compromise the seal and introduce air into the 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 can introduce air into a line used for cardioplegia delivery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 165 units of the Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 (Item Number: 16110). This product is a replacement line for multiple cardioplegia delivery sets and includes the female luer connector that is the subject of this correction/removal activity.
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 line. The affected units were manufactured between September 13, 2010, and October 4, 2010, and include lot numbers ML13 and MM04.
The affected products were distributed nationwide in the United States, as well as in Canada, Brazil, Hong Kong, Korea, and Thailand. Healthcare facilities and distributors should stop using the affected product and contact Terumo Cardiovascular Systems Corp for further instructions.
The recalled product
- Product
- Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 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 activi
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 165
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 (4)
- Lot Numbers: ML13
- MM04. Manufacturing datese September 13
- 2010 through October 4
- 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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