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 custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Maquet Cardiovascular is recalling specific adult extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all fluid paths.
Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow.
Maquet Cardiovascular is recalling specific ECC tubing sets because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization gas flow.
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 batches of BO-TOP 48400 OR PACK tubing sets because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific neonate extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-T 5211 Large ECC Sets because a design feature may prevent proper sterilization.
Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, 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.
Maquet Cardiovascular is recalling specific ECC pump packs because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling BEQ-TOP 32200 ECC Packs because a design flaw may prevent sterilization gas from reaching all fluid paths, compromising sterility.
Maquet Cardiovascular is recalling specific infant extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
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 batches of BEQ-TOP 37200 E-Circuit Bioline Heparin tubing sets 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 proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design configuration may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific adult specialty tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.