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Showing 3721–3740 of 68218 results

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AnchorFast Oral Endotracheal Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

FDADec 23, 2024Nationwide• Hollister Incorporated

Lev5 Susceptibility Discs (Oxoid) – Mislabeling Risk (2024)

Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.

FDADec 23, 2024CA, FL, MA +4 more• Oxoid Limited Wade Road Basingstoke United Kingdom

Astagraf XL 0.5mg (Astellas) – empty capsules risk (2024)

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Class IHigh

FDADec 23, 2024Nationwide• Astellas Pharma US Inc.

Cardura XL 8mg (Viatris) – impurity specification failure (2024)

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Class IIModerate

FDADec 23, 2024Nationwide• Viatris Inc

Ultra Repair Cream (First Aid Beauty) – distribution error (2024)

CGMP Deviations; product intended for quarantine was inadvertently distributed

Class IIModerate

FDADec 23, 2024Nationwide• First Aid Beauty Ltd

Prograf 0.5mg (Astellas) – empty capsules risk (2024)

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

FDADec 23, 2024Nationwide• Astellas Pharma US Inc.

AnchorFast Guard Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

FDADec 23, 2024Nationwide• Hollister Incorporated

Cardura XL 4mg (Viatris) – impurity specification failure (2024)

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Class IIModerate

FDADec 23, 2024Nationwide• Viatris Inc

ETHIBOND EXCEL Polyester Suture (Ethicon) – Packaging Seal Defect (2024)

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

FDADec 20, 2024Nationwide• Ethicon, LLC

Smart Drive MX2+ SpeedControl Dial (Max Mobility) – Circuit Board Fault (2024)

Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.

FDADec 20, 2024AL, AK, AZ +49 more• Max Mobility LLC

Life 2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

PROLENE Polypropylene Suture (Ethicon) – Packaging Seal Issue (2024)

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

FDADec 20, 2024Nationwide• Ethicon, LLC

Baxter Solution Set (Baxter) – Inverted Side Clamps (2024)

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

AXIOS Stent Delivery System (Boston Scientific) – Outer Sheath Detachment (2024)

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

FDADec 20, 2024Nationwide• Boston Scientific Corporation

PERMA-HAND Silk Suture (Ethicon) – Packaging Seal Defect (2024)

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

FDADec 20, 2024Nationwide• Ethicon, LLC

Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

AXIOS Stent Delivery System (Boston Scientific) – Stent Saddle Problem (2024)

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

FDADec 20, 2024Nationwide• Boston Scientific Corporation

Lipoprotein (a) Test (Randox) – 510(k) Compliance Issue (2024)

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

FDADec 20, 2024Nationwide• Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom

Rajbhog Jelebi Jaggery (Rajbhog Distributors) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk

Class IIModerate

FDADec 20, 2024TX• Rajbhog Distributors TX Inc.

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