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Showing 3261–3280 of 11714 results

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Diced Bartlett Pears (Pacific Coast Producers) – Foreign Objects (2024)

Potential contamination with foreign objects.

Class IIModerate

FDADec 5, 2024KY, MI, OH +1 more• Pacific Coast Producers

VITROS Chemistry Products (Quidel Ortho) – Hemoglobin Interference (2024)

Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.

FDADec 5, 2024Nationwide• QUIDEL ORTHO

LINK MP Reconstruction System (Waldemar Link) – Incorrect Label Size (2024)

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

Moderate

FDADec 5, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Hillrom Temperature Management Controller (Augustine) – Instructions Update (2024)

Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

FDADec 4, 2024Nationwide• Augustine Temperature Management, LLC

Spinal/Epidural Tray (B. Braun) – Catheter Connector Mismatch (2024)

Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.

FDADec 4, 2024Nationwide• B. Braun Medical, Inc.

Nitrofurantoin Capsules 100mg (AvKARE) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDADec 4, 2024Nationwide• AvKARE

Hot Dog Patient Warming Controller (Augustine) – Instructions Update (2024)

Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

FDADec 4, 2024Nationwide• Augustine Temperature Management, LLC

Organic Pecan Halves (Pecan Star) – Undeclared Walnuts (2024)

Undeclared Allergen

Undeclared walnuts

Class IIModerate

FDADec 4, 2024AL, FL, GA +5 more• Pecan Star & Nut Corp.

Medtronic PIN (Medtronic) – Reference Frame Fitting Issue (2024)

Laceration Risk

Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.

FDADec 4, 2024Nationwide• Medtronic Navigation, Inc.

ECONO STERILE Trousseau Dilator (Sklar) – Packaging Sterility Breach (2024)

Reports of various packaging issues that may result in a breach of the sterile barrier.

FDADec 3, 2024Nationwide• Sklar Instruments

ECONO STERILE Surgical Scissors (Sklar) – Packaging Sterility Breach (2024)

Reports of various packaging issues that may result in a breach of the sterile barrier.

FDADec 3, 2024Nationwide• Sklar Instruments

UNiD Spine Analyzer (Unknown) – Rod Planning Software Error (2024)

Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.

FDADec 3, 2024AL, AK, AZ +47 more

FastPack SHBG Immunoassay (Qualigen) – Incorrect Expiration Date (2024)

Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.

FDADec 3, 2024AR, CA, CO +12 more• Qualigen Inc

ECONO STERILE Medical Kits (Sklar) – Packaging Sterility Breach (2024)

Reports of various packaging issues that may result in a breach of the sterile barrier.

FDADec 3, 2024Nationwide• Sklar Instruments

Neptune 3 Rover (Stryker) – Vacuum Pump Filter Housing Issue (2024)

Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.

FDADec 3, 2024GA, IL, WA• Stryker Corporation

Folysil Foley Catheters (Coloplast) – Sterility Concern (2024)

A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

FDADec 2, 2024Nationwide• Coloplast Manufacturing US, LLC

Change Healthcare Cardiology Software (ALI Technologies) – Medication Error Risk (2024)

Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

FDADec 2, 2024Nationwide• A L I Technologies Ltd

Headway Microcatheter (MicroVention) – Inner Packaging Seal Defect (2024)

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

FDADec 2, 2024Nationwide• MICROVENTION INC.

X-Flow Prostatectomy Catheter (Coloplast) – Sterility Issue (2024)

A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

FDADec 2, 2024Nationwide• Coloplast Manufacturing US, LLC

Duloxetine Capsules 60mg (RemedyRepack) – CGMP Impurity Limit (2024)

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 2, 2024Nationwide• RemedyRepack Inc.

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