FDA-Device2014-11-12Class II
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 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
Terumo Cardiovascular Systems Corp
Hazard
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
Sold states
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Affected count
24 units
Manufactured in
28 Howe St, N/A, Ashland, MA, United States
Products
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0161-2015Don't want to check this manually?
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