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MEGA Intra-Aortic Balloon (Datascope) – Packaging Labeling Discrepancy (2024)

There is discrepant labeling on the inner and outer packaging of the device.

FDASep 17, 2024Nationwide• Datascope Corp.

Check-Flo Performer Introducer Set (Cook) – Shaft Connection Problem (2024)

Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.

FDASep 16, 2024Nationwide• Cook Incorporated

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MEGA Intra-Aortic Balloon (Datascope) – Packaging Labeling Discrepancy (2024)

Check-Flo Performer Introducer Set (Cook) – Shaft Connection Problem (2024)

ClariTEE Probe (ImaCor) – Epoxy Seal Signal Attenuation (2024)

Phasitron5 Breathing Circuit (Percussionaire) – Fluid Discoloration Issue (2024)

Graft Tube (Spineology) – Shaft Detachment Risk (2024)

Ambu VivaSight 2 DLT Tube (Ambu) – Distal End Angulation Risk (2024)

Refresh P.M. Eye Ointment (AbbVie) – Tube Seal Breach (2024)

Refresh LACRI-LUBE (AbbVie) – Tube Seal Breach (2024)

MEDIHONEY Wound Dressing (Integra) – Sterility Pinhole Concern (2024)

EZDilate Wire Guided Balloon (Olympus) – Mislabeled Size Concern (2024)

Z-800 Infusion System (Zyno Medical) – Air-in-Line Software Defect (2024)

Olympus Cystoscope Outer Sheath (Olympus) – Compatibility Statement Removal (2024)

17-OH Progesterone ELISA Kit (DRG) – Control Range Mismatch (2024)

BD Synapsys (Becton Dickinson) – Software Error (2024)

Abbott Alinity m STI AMP Kit (Abbott) – Error Code Issue (2024)

Abbott Alinity m HPV AMP Kit (Abbott) – Error Code Problem (2024)

Welch Allyn Life2000 (Baxter) – Pressure Alarm Failure (2024)

LINK Universal Handle (Waldemar Link) – Material Failure Risk (2024)

UroPass Ureteral Access Sheaths (Olympus) – UV Radiation Damage (2024)

SynchroMed II Infusion Pump (Medtronic) – Memory Corruption (2024)