Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: Recalled by Terumo Cardiovascular Systems Corp Due to Defect in the luer connector can compromise the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corp directly.
Affected Products
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 activity
Quantity: 165 units
Why Was This Recalled?
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Systems Corp has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report