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Showing 4761–4780 of 11714 results

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Losartan Hydrochlorothiazide (Macleods) – Plastic Contamination (2024)

Presence of foreign substance: plastic-like substance.

Class IIModerate

FDAMay 7, 2024Nationwide• MACLEODS PHARMA USA, INC

Zilretta Injection (Pacira) – Stability Specification Failure (2024)

Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

Class IIModerate

FDAMay 7, 2024Nationwide• PACIRA PHARMACEUTICALS INC

Cataract Pack Kit (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber

High

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

NovaGuide 2 Ultrasound (NovaSignal) – Electrical Shock Risk (2024)

Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.

FDAMay 6, 2024Nationwide• NovaSignal Corp.

Hand Pack Kit (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Biopsy Drape Pack (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Gyn Laparoscopy Kit (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Special Procedure Pack (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Spine Pack Kit (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Extremity Convenience Kit (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

NovaGuide 2 Traditional Ultrasound (NovaSignal) – Electrical Shock Risk (2024)

Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.

FDAMay 6, 2024Nationwide• NovaSignal Corp.

Laparoscopy Litho Pack (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Metoprolol Tablets (Rubicon) – Metal Contamination (2024)

Presence of Foreign Substance: metal in tablet

Class IIModerate

FDAMay 6, 2024Nationwide• Rubicon Research Private Limited

ADVANTA VXT Vascular Graft (Atrium) – Slider Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

SmartPath 1.5T MRI System (Philips) – Electrical Fire Risk (2024)

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

FDAMay 3, 2024Nationwide• Philips North America Llc

Sonalleve MR HIFU 3.0T System (Philips) – Electrical Fire Risk (2024)

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

FDAMay 3, 2024Nationwide• Philips North America Llc

ADVANTA VXT Vascular Graft (Atrium) – Slider Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

ADVANTA VXT Vascular Graft (Atrium) – Slider Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

Ingenia 3.0T CX MRI System (Philips) – Electrical Fire Risk (2024)

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

FDAMay 3, 2024Nationwide• Philips North America Llc

FLIXENE Vascular Graft (Atrium) – Slider Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

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