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PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .03... (Cordis US Corp) – potential for stent dislodgement and ... (2022)

Potential for stent dislodgement and associated failures related to two specific sizes of the device.

FDAMay 20, 2022Nationwide• Cordis US Corp

EIT CIF cage, H 7mm, 8degree, S- an intervertebral body f... (DePuy Spine, Inc.) – label on the outer carton does not ma... (2022)

Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

FDAMay 20, 2022Nationwide• DePuy Spine, Inc.

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PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .03... (Cordis US Corp) – potential for stent dislodgement and ... (2022)

EIT CIF cage, H 7mm, 8degree, S- an intervertebral body f... (DePuy Spine, Inc.) – label on the outer carton does not ma... (2022)

EIT CIF cage, H 6mm, 8degree, L- an intervertebral body f... (DePuy Spine, Inc.) – label on the outer carton does not ma... (2022)

Artis Icono, Interventional Fluoroscopic X-Ray System, Mo... (Siemens Medical Solutions USA, Inc) – during system tests, an increased wea... (2022)

Sensica Urine Output System (C.R. Bard Inc) – complaints relating to urine output m... (2022)

ABL800 Flex Analyzer (Radiometer) – Potential Bias (2022)

Baby Gorilla Plating System (Paragon 28) – Incorrect Labeling (2022)

Modular Cathcart Fracture Hip Ball (DePuy) – Offset Discrepancy (2022)

MAC F/O Laryngoscope (Baxter) – Packaging Error (2022)

VSP Reconstruction (Medical Modeling) – Design Issue (2022)

Drager SafeStar 55 (Draeger) – Filter Occlusion (2022)

Volcano Visions IVUS Catheter (Volcano) – IFU Omission (2022)

RayOne IOL (Rayner) – Mislabeled Package (2022)

NeuMoDx Flu Test Strip (NeuMoDx) – Sensitivity Reduction (2022)

EEA Circular Stapler (Unknown) – Staple Guide Risk (2022)

Medline Pill Splitters (Medline) – Blade Exposure (2022)

Vygon Dressing Kit (Stradis) – Seal Incompleteness (2022)

CARESCAPE Central Station (GE Healthcare) – Power Supply Failure (2022)

Vapor-Clean Filter (Dynasthetics) – Manufacturing Defect (2022)

BD Connecta Plus1 360 (Becton Dickinson) – Leakage Risk (2022)