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Showing 9921–9940 of 11714 results

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Foundation Kit (Stradis) – Manufacturing Standards Issue (2021)

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

FDASep 10, 2021Nationwide• Stradis Medical, LLC dba Stradis Healthcare

IUD Insertion Kit (Stradis) – Manufacturing Standards Issue (2021)

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

FDASep 10, 2021Nationwide• Stradis Medical, LLC dba Stradis Healthcare

Babylog VN500 Ventilator (Draeger) – Software Restart Risk (2021)

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

FDASep 10, 2021Nationwide• Draeger Medical, Inc.

IUD Insertion Pack (Stradis) – Manufacturing Standards Issue (2021)

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

FDASep 10, 2021Nationwide• Stradis Medical, LLC dba Stradis Healthcare

FlexLab Automation System (Inpeco) – Test Result Association Error (2021)

The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.

FDASep 10, 2021Nationwide• Inpeco S.A. Via San Gottardo 10 Lugano Switzerland

Endometrial Biopsy Kit (Stradis) – Manufacturing Standards Issue (2021)

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

FDASep 10, 2021Nationwide• Stradis Medical, LLC dba Stradis Healthcare

FIVE S Intubation Videoscope (Karl Storz) – Sterility Assurance Risk (2021)

During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.

FDASep 10, 2021AL, AZ, AR +37 more• Karl Storz Endoscopy

Evita V500 Ventilator (Draeger) – Software Restart Risk (2021)

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

FDASep 10, 2021Nationwide• Draeger Medical, Inc.

C315-HIS Delivery Catheter (Medtronic) – Lead Passage Issue (2021)

Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

FDASep 9, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Cardiosave Rescue IABP (Datascope) – Power Shutdown Risk (2021)

The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.

FDASep 8, 2021Nationwide• Datascope Corp.

Cardiosave Hybrid IABP (Datascope) – Helium Indicator Error (2021)

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

FDASep 8, 2021Nationwide• Datascope Corp.

Cardiosave Rescue IABP (Datascope) – Helium Indicator Error (2021)

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

FDASep 8, 2021Nationwide• Datascope Corp.

Cardiosave Hybrid IABP (Datascope) – Power Shutdown Risk (2021)

The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.

FDASep 8, 2021Nationwide• Datascope Corp.

Vit Kit-Freeze (Fujifilm Irvine) – Incorrect Expiration Date (2021)

Due to a component in kit being labeled with the incorrect Expiration Date

FDASep 8, 2021Nationwide• Fujifilm Irvine Scientific, Inc.

BD Nexiva Catheter (Becton Dickinson) – Packaging Sterility Issue (2021)

There is a breach in the product packaging that renders the product non-sterile.

FDASep 8, 2021Nationwide• Becton Dickinson Infusion Therapy Systems Inc.

Gel Conductor (DJO) – Bacterial Contamination Risk (2021)

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

FDASep 7, 2021Nationwide• DJO, LLC

GORE VIABAHN VBX (W L Gore) – Incorrect Labeling (2021)

Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.

FDASep 7, 2021Nationwide• W L Gore & Associates, Inc.

Ultra-Myossage Lotion (DJO) – Bacterial Contamination Risk (2021)

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

FDASep 7, 2021Nationwide• DJO, LLC

ELI 280 Electrocardiograph (Welch Allyn) – Workflow Malfunction (2021)

The devices malfunction under specific operator workflows.

FDASep 3, 2021Nationwide• Welch Allyn Inc Mortara

cobas EGFR Mutation Test (Roche) – False Mutation Detection (2021)

False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment

FDASep 3, 2021Nationwide• Roche Molecular Systems, Inc.

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