ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port recall — FDA Z-0337-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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The newest recall records with useful source details are listed here.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment…
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct…
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan…
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary…
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary…
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Potential for contamination with cotton fibers.
Due to incomplete seals in the pouch which provide the sterile barrier.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage…
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage…
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan…
Potential for a weak seal in some units resulting in compromise in sterility.
Browse recent months with enough recall history for useful comparison.