FDA-Device2018-08-01Class II
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
Terumo Cardiovascular Systems Corp
Hazard
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
Sold states
US state of FL
Affected count
30 cases/2 units (Total 60 units)
Manufactured in
28 Howe St, N/A, Ashland, MA, United States
Products
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2550-2018Don't want to check this manually?
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