ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 recall — FDA Z-0353-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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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.
Undeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement
Undeclared Peanuts. The firm received two complaints that the product contains peanuts which are not listed in the ingredient statement.
Undeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement
undeclared milk allergen
undeclared milk allergen
Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Undeclared shrimp
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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