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EZ2 Connect MDx-IVD (Qiagen) – Heater Cable Failure (2024)

Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost

Moderate

FDAMar 4, 2024Nationwide• Qiagen Sciences LLC

NEOMED Pharmacy Syringes (Avanos) – Expiration Date Omission (2024)

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

Low

FDAMar 4, 2024Nationwide• Avanos Medical, Inc.

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EZ2 Connect MDx-IVD (Qiagen) – Heater Cable Failure (2024)

NEOMED Pharmacy Syringes (Avanos) – Expiration Date Omission (2024)

Dilator (Cook) – Packaging Seal Strength Issue (2024)

Entuit Suture Anchor Set (Cook) – Packaging Seal Strength Issue (2024)

Phantom 2 Nasal Vented Mask (SleepNet) – Magnet Warning Update (2024)

Mojo Non Vented Full Face Mask (SleepNet) – Magnet Warning Update (2024)

Mojo Full Face with Headgear (SleepNet) – Magnet Warning Update (2024)

Mojo 2 Full Face Non Vented Mask (SleepNet) – Magnet Warning Update (2024)

HeNe Laser System (Pacific LaserTech) – Key Control Noncompliance (2024)

Triangle Tip Electrosurgical Knives (Olympus) – Breakage Warning (2024)

Dilator With AQ Hydrophilic Coating (Cook) – Packaging Seal Strength Issue (2024)

HeartMate 3 LVAS Implant Kit (Thoratec) – Potential Leak Risk (2024)

Medline Medical Procedure Kits (Medline) – Needle Guide Ring Detachment (2024)

Liquid Protein Calibrators (Randox) – Calibration Realignment (2024)

Centurion OB Instrument Tray (Medline) – Needle Guide Ring Detachment (2024)

Trocar Needle (Cook) – Packaging Seal Strength Issue (2024)

Dilator Coons Taper (Cook) – Packaging Seal Strength Issue (2024)

Peel-Away Introducer (Cook) – Packaging Seal Strength Issue (2024)

Cholestech LDX Battery Kit (Alere) – Battery Pack Issue (2024)

iQ 2 Nasal Vented Mask (SleepNet) – Magnet Warning Update (2024)