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All product recalls affecting New Hampshire.
Includes nationwide recalls (tagged “Nationwide”) and recalls with New Hampshire in the distribution area.
Labeling contains claims that are not consistently present.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.