FDA-Device2019-06-05Class II
Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
Maquet Cardiovascular, LLC
Hazard
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Sold states
Nationwide
Affected count
N/A
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1656-2019Don't want to check this manually?
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