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IsoLoc Prostate Balloon (Angiodynamics) – Mislabeling Risk (2024)

A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).

Low

FDAMay 21, 2024Nationwide• Angiodynamics, Inc.

VITROS Chemistry Diluent Pack (Ortho-Clinical) – Sample Result Bias (2024)

VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.

Moderate

FDAMay 21, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

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IsoLoc Prostate Balloon (Angiodynamics) – Mislabeling Risk (2024)

VITROS Chemistry Diluent Pack (Ortho-Clinical) – Sample Result Bias (2024)

Pink Luminous Breast Device (Silkprousa) – Unapproved Marketing (2024)

VASOVIEW HemoPro Harvesting Systems (Maquet) – Fluid Ingress Problem (2024)

RAPIDPoint 500e Blood Gas System (Siemens) – Sample Source Identification (2024)

Stimuplex A 30 DEG 20GX6 (B Braun) – DEHP Trace Glue (2024)

Cascade IOMAX Cortical Module (Cadwell) – Circuit Board Defect (2024)

Stimuplex A 30 DEG 21GX4 (B Braun) – DEHP Trace Glue (2024)

Stimuplex A 30 DEG 24GX1 (B Braun) – DEHP Trace Glue (2024)

VASOVIEW HemoPro 2 Harvesting System (Maquet) – Fluid Ingress Risk (2024)

Fathom Pedicle-Based Retractor (SEASPINE) – Blade Fracture Risk (2024)

Stimuplex A 30 DEG 22GX2 (B Braun) – DEHP Trace Glue (2024)

RingLoc Bi-Polar Hip System Cup (Biomet) – Joint Instability Risk (2024)

Abbott Proclaim Plus 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Abbott Proclaim XR 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Abbott Liberta RC Pulse Generator (Abbott Medical) – System Deactivation (2024)

US AquaA 900H Water Purifier (Fresenius) – Concentrate Flow Error (2024)

Abbott Proclaim 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Abbott Proclaim DRG Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Abbott Proclaim XR 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)