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Polident Denture Cleansers (Family Dollar) – Improper Temperature Storage (2022)

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Cobalt Implantable Cardioverter Defibrillator (Medtronic) – Reduced Shock Energy (2022)

There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

FDAJun 22, 2022Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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Polident Denture Cleansers (Family Dollar) – Improper Temperature Storage (2022)

Cobalt Implantable Cardioverter Defibrillator (Medtronic) – Reduced Shock Energy (2022)

CVS Health Surgical Pads (ASO) – Product Disintegration Problem (2022)

Crome Implantable Cardioverter Defibrillator (Medtronic) – Reduced Shock Energy (2022)

E-100 Generator (Intuitive Surgical) – Maintenance Performance Issue (2022)

Revogene (Meridian Bioscience) – Cooling Period Safety Issue (2022)

CereLink ICP Monitor (Integra) – Pressure Reading Drift Problem (2022)

AquaC UNO H Reverse Osmosis Unit (Fresenius) – Electromagnetic Compatibility Issue (2022)

etouchus Blood Glucose Meter (Touch US) – FDA Clearance Missing (2022)

AquaC UNO H (Fresenius) – Ethernet Cable Ferrite Core Missing (2022)

Simplify Disc (NuVasive) – UDI Barcode Error (2022)

BD Intraosseous Needle Kit (Bard Access) – Stylet Removal Risk (2022)

Verigene CDF Test (Luminex) – False Negative Risk (2022)

Merlin PCS Programmer (St. Jude Medical) – Software Display Error (2022)

VERIGENE Enteric Pathogens Test (Luminex) – False Negative Risk (2022)

Merlin.net Software (St. Jude Medical) – Programming System Design (2022)

Merlin 2 PCS Programmer (St. Jude Medical) – Programming System Design (2022)

AquaC UNO H Reverse Osmosis Unit (Fresenius) – Ethernet Cable Risk (2022)

OB/GYN Packs (American Contract) – Sterilization Cycle Concern (2022)

Port Insertion Packs (American Contract) – Sterilization Cycle Concern (2022)