FDA (Devices) recall action 82703
The FDA (Devices) publishes a recall like this one as 183 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 183 pages.
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
The agency’s own wording, quoted from the enforcement report.
Maquet Cardiovascular is recalling specific BEQ-TOP 5210 ECC Sets because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Custom CPB Packs because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Pediatric Cardiac Surgery Packs because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the stopcock design may prevent sterilization gas from reaching all fluid paths.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Pressure Pigtail devices because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.