FDA-Device2014-11-12Class II
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activ
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: 16579 ; Catalog 6375: 3256 units
Manufactured in
28 Howe St, N/A, Ashland, MA, United States
Products
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2015Don't want to check this manually?
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