FDA-Device2018-06-13Class III
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
Datascope Corporation
Hazard
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
Sold states
The products were distributed to the following US states: AL, OR, and TX.
Affected count
194 total kits
Manufactured in
15 Law Dr, N/A, Fairfield, NJ, United States
Products
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2105-2018Don't want to check this manually?
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