FDAApril 18, 2019device
Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
Official recall recorded by the U.S. Food & Drug Administration.
The 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
What to do
FDA enforcement status: Terminated
Brands named
maquet cardiovascularmaquet
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAHeartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.2025-08-15
- FDAHeartstring III Proximal Seal System. Intravascular anastomosis occluder.2025-08-15
- FDAVasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting T...2025-08-06
- FDACorin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.2025-07-14
- FDASprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.2025-06-27
- FDAServo-n Ventilator System. Model Number: 6694800.2025-05-30
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