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Thermalon Stye Compress (Bruder) – Moisture Exposure Risk (2024)

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Moderate

FDAFeb 21, 2024Nationwide• Bruder Healthcare Company, LLC

MediBeads King Pad (Bruder) – Moisture Exposure Risk (2024)

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Moderate

FDAFeb 21, 2024Nationwide• Bruder Healthcare Company, LLC

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Thermalon Stye Compress (Bruder) – Moisture Exposure Risk (2024)

MediBeads King Pad (Bruder) – Moisture Exposure Risk (2024)

Thermalon Eye Compress (Bruder) – Moisture Exposure Risk (2024)

Thermalon Neck Wrap (Bruder) – Moisture Exposure Risk (2024)

Nimbus Infusion Set (InfuTronix) – Multiple Failure Modes (2024)

MediBeads Neck Wrap (Bruder Healthcare) – Moisture Risk (2024)

Thermalon Back Wrap (Bruder) – Moisture Exposure Risk (2024)

Thermalon Sinus Compress (Bruder) – Moisture Exposure Risk (2024)

Situate Laparotomy Sponge (Covidien) – Incorrect Product (2024)

Obsidio Embolic (Boston Scientific) – Delivery Technique Risk (2024)

EndoVive PEG Kit (Boston Scientific) – Guidewire Blockage (2024)

EndoVive PEG Kit (Boston Scientific) – Guidewire Blockage (2024)

3M Tube Securement Device (3M) – Manufacturing Defect (2024)

Cardiovascular Procedure Kits (Terumo) – Pressure Valve Issue (2024)

EndoVive PEG Kit (Boston Scientific) – Guidewire Blockage (2024)

Halyard Surgical Hood (O & M Halyard) – Mislabeling Risk (2024)

iSLEEVE Introducer Set (Boston Scientific) – Hemostasis Concern (2024)

EsteemBody Soft Convex Pouch (ConvaTec) – Inconsistency Risk (2024)

HeartMate 3 LVAS (Thoratec) – Outflow Graft Obstruction (2024)

HeartMate II LVAS (Thoratec) – Outflow Graft Obstruction (2024)