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Showing 7301–7320 of 8389 results

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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): C315-HIS Delivery Catheter

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)

Fujifilm Irvine Scientific, Inc.: Vit Kit-Freeze is intended for use in assisted reproducti...

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

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

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model...

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.

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model...

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.

Becton Dickinson Infusion Therapy Systems Inc.: BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/...

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

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

Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model...

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.

Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model...

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.

DJO, LLC: GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8...

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

DJO, LLC: Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossa...

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

W L Gore & Associates, Inc.: Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHES...

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.

Roche Molecular Systems, Inc.: cobas EGFR Mutation Test v2-Somatic gene mutation detecti...

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.

Welch Allyn Inc Mortara: ELI, Burdick and McKesson brand 280 Resting Electrocardio...

The devices malfunction under specific operator workflows.

FDASep 3, 2021Nationwide• Welch Allyn Inc Mortara

W L Gore & Associates, Inc.: REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

W L Gore & Associates, Inc.: REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

W L Gore & Associates, Inc.: REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

W L Gore & Associates, Inc.: REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

W L Gore & Associates, Inc.: REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

W L Gore & Associates, Inc.: REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

W L Gore & Associates, Inc.: REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

W L Gore & Associates, Inc.: REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

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