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Showing 5541–5560 of 8389 results

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ACL ELITE Analyzer (Instrumentation) – Test Definition Removal (2023)

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

FDAFeb 3, 2023Nationwide• Instrumentation Laboratory

ACL ELITE Analyzer (Instrumentation) – Test Definition Removal (2023)

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

FDAFeb 3, 2023Nationwide• Instrumentation Laboratory

Sit to Stand Patient Lift (Med-Mizer) – Boom Pivot Failure (2023)

Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.

High

FDAFeb 3, 2023Nationwide• Med-Mizer, Inc.

BEAR Implant (Miach Orthopaedics) – Limited Field Action (2023)

The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

FDAFeb 2, 2023Nationwide• Miach Orthopaedics

ORTHOLOC 3DSi Plate (Wright Medical) – Lot Commingling (2023)

Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.

FDAFeb 2, 2023Nationwide• Wright Medical Technology, Inc.

Habib EndoHPB RF Catheter (Boston Scientific) – Excessive Energy Risk (2023)

Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").

FDAFeb 2, 2023Nationwide• Boston Scientific Corporation

ARTIS Pheno System (Siemens) – Unintended Table Movement (2023)

In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

FDAFeb 2, 2023Nationwide• Siemens Medical Solutions USA, Inc

LATITUDE NXT System (Boston Scientific) – Registration Failure (2023)

Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..

FDAFeb 2, 2023Nationwide• Boston Scientific Corporation

MicroVue C1-Inhibitor EIA (Quidel) – Low OD Values (2023)

Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

FDAFeb 1, 2023Nationwide• Quidel Corporation

MiniCap Disconnect Cap (Baxter) – Incorrect Sealing (2023)

MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.

FDAFeb 1, 2023Nationwide• Baxter Healthcare Corporation

BD Ultra-Fine Insulin Syringe (BD) – Nonsterile Risk (2023)

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

FDAFeb 1, 2023Nationwide• Becton Dickinson & Company

BIOPHEN Protein C Kit (Aniara) – Chemical Substance Warning (2023)

New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility

FDAFeb 1, 2023Nationwide• Aniara Diagnostica LLC

BD Ultra-Fine II Insulin Syringe (BD) – Nonsterile Risk (2023)

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

FDAFeb 1, 2023Nationwide• Becton Dickinson & Company

BioFire BCID2 Panel (BioFire) – Temperature Excursion (2023)

Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.

FDAFeb 1, 2023Nationwide• BioFire Diagnostics, LLC

BD Insulin Syringe (BD) – Nonsterile Risk (2023)

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

FDAFeb 1, 2023Nationwide• Becton Dickinson & Company

Heartsine Samaritan PAD (HeartSine) – Language Configuration (2023)

Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.

FDAFeb 1, 2023AZ, AR, CA +5 more• HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom

TFN-Advanced Femoral Nail (Synthes) – Length Mismatch (2023)

TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length

FDAFeb 1, 2023Nationwide• Synthes (USA) Products LLC

Plato 17 Microcatheter (Scientia Vascular) – Manufacturing Nonconformance (2023)

Laceration Risk

Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to placement, may have loose particles within catheter lumens that may be introduced to patients, which could cause embolic event, small vessel occlusion, and subacute to chronic inflammatory response.

FDAFeb 1, 2023Nationwide• Scientia Vascular, Inc.

PREAT NOBIL GRIP (Preat) – Incorrect Expiration (2023)

Product is labeled with an incorrect expiration date.

FDAFeb 1, 2023Nationwide• Preat Corp

CRP Immunoturbidimetric Reagent (Randox) – Antibody Bias (2023)

The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range

FDAFeb 1, 2023OH, PA, WV• Randox Laboratories

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