FDA-Device2014-11-12Class II
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the
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
Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units
Manufactured in
28 Howe St, N/A, Ashland, MA, United States
Products
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0159-2015Don't want to check this manually?
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