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Amicus Exchange Kit (Fenwal) – Potential Stress Leak (2023)

Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.

Moderate

FDAFeb 14, 2023Nationwide• Fenwal Inc

KLS E-Coupling Adapter (Pro-Dex) - Incorrect Device Identifier (2023)

Incorrect Unique Device Identifier/GTIN code was used on product.

Low

FDAFeb 14, 2023Nationwide• Pro-Dex Inc

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Amicus Exchange Kit (Fenwal) – Potential Stress Leak (2023)

KLS E-Coupling Adapter (Pro-Dex) - Incorrect Device Identifier (2023)

BD Pyxis MedStation Tower (CareFusion) - Door Latch Failure (2023)

Brainlab ExacTrac Software (Brainlab) - Breath Hold Functionality (2023)

Amicus MNC Apheresis Kit (Fenwal) – Potential Stress Leak (2023)

BD Pyxis Med ES Auxiliary (CareFusion) – Medication Access Risk (2023)

BD Pyxis Anesthesia System (CareFusion) - Firmware Downgrade (2023)

BD Pyxis MedStation 4000 (CareFusion) – Medication Access Risk (2023)

BD Pyxis Med 4000 Auxiliary (CareFusion) – Medication Access Risk (2023)

BD Pyxis MedStation 4000 AUX (CareFusion) – Medication Access Risk (2023)

BD Pyxis MedStation (CareFusion) - Drawer Failure (2023)

BD Pyxis MedStation ES (CareFusion) – Medication Access Risk (2023)

Lifeline AED (Defibtech) - Component Reliability (2023)

Swan-Ganz CCOmbo V Catheter (Edwards) - Curvature Problem (2023)

Swan-Ganz CCOmbo V Catheter (Edwards) - Curvature Problem (2023)

FreeStyle Libre Reader (Abbott) – Battery Fire Risk (2023)

FreeStyle Libre Reader (Abbott) – Battery Fire Risk (2023)

Global Total LP Medium (CooperSurgical) – Incorrect Medium (2023)

BEQ-HLS Medical Set (Maquet) – Packaging Sterility Concern (2023)

DreamStation CPAP (Philips) – Communication Problem (2023)