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Bard Marquee Biopsy Kit (Bard) – Needle Diameter Mismatch (2023)

Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.

Moderate

FDAAug 10, 2023Nationwide• Bard Peripheral Vascular Inc

Welch Allyn Connex Monitor (Baxter) – Display Tape Placement (2023)

Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

Moderate

FDAAug 10, 2023

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Bard Marquee Biopsy Kit (Bard) – Needle Diameter Mismatch (2023)

Welch Allyn Connex Monitor (Baxter) – Display Tape Placement (2023)

Arrow ErgoPack PICC (Arrow) – Product Label Mismatch (2023)

VITROS Chemistry Proboscis Assembly (Ortho-Clinical) – Manufacturing Issue (2023)

FluidShield N95 Respirator (Halyard) – Filtration Efficiency Failure (2023)

Fresenius 10ML Syringe (Fresenius) – Leakage Potential (2023)

Fresenius 3ML Syringe (Fresenius) – Leakage Potential (2023)

Mallinckrodt One-Way Valve (Mallinckrodt) – Airflow Restriction (2023)

Fresenius 10ML Syringe with Needle (Fresenius) – Leakage Potential (2023)

Oculus Pentacam AXL Wave (Oculus) – Coating Measurement Risk (2023)

Oculus Myopia Master (Oculus) – Coating Measurement Risk (2023)

Prucka 3 Amplifiers (GE Medical) – Power Supply Failure (2023)

Oculus Pentacam AXL (Oculus) – Coating Measurement Risk (2023)

FX Shoulder Glenosphere (FX Shoulder) – Component Mismatch (2023)

ADVIA Chemistry Iron Reagents (Siemens) – QC Result Bias (2023)

B. Braun NORM-JECT Luer Solo (B. Braun) – Packaging Sterility (2023)

Heartmate 3 LVAS Kit (Thoratec) – Coring Knife Sharpness (2023)

Stryker ACM Cement Mixing System (Stryker) – Nozzle Breakage Risk (2023)

B. Braun NORM-JECT Luer Lock (B. Braun) – Packaging Sterility (2023)

VITROS XT ALKP Slides (Ortho-Clinical) – Substrate Depletion (2023)