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Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01
Recalled June 5, 2019 · FDA recall Z-1650-2019 · Maquet Cardiovascular
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 · FDA Class II
Units
N/A
Sold at
Nationwide
Description
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
Product
Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01
Manufacturer(s)
Maquet Cardiovascular, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →