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Showing 6261–6280 of 11714 results

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Monarch Platform (Auris Health) – image view risk (2023)

Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

FDAOct 18, 2023AL, AK, AZ +31 more• AURIS HEALTH INC

Midazolam Injection (Exela Pharma) – Particulate Problem (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

LYFO-DISK P. venetum (Microbiologics) – contamination risk (2023)

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

Moderate

FDAOct 18, 2023Nationwide• Microbiologics Inc

ELCYS Injection (Exela Pharma) – Particulate Contamination (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Sodium Bicarbonate Injection (Exela Pharma) – Particulate Issue (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Lugol's Iodine Solution (EMD Millipore) – packaging seal issue (2023)

Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.

FDAOct 17, 2023CA, NJ, WV• EMD Millipore Corporation

ARTIS icono (Siemens) – collision sensor problem (2023)

Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.

FDAOct 17, 2023Nationwide• Siemens Medical Solutions USA, Inc

FilmArray TORCH (BioFire) – power switch risk (2023)

Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.

FDAOct 17, 2023Nationwide• BioFire Diagnostics, LLC

SagiPlan 2.2 (Bebig) – measurement accuracy issue (2023)

Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.

FDAOct 17, 2023MD• Bebig Isotopentechnik Gmbh Robert-Rossle-Str. 10 Berlin Germany

BIOFIRE Blood Culture Panel (BioFire) – control panel problem (2023)

Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.

FDAOct 17, 2023Nationwide• BioFire Diagnostics, LLC

Synthroid Levothyroxine Tablets (AbbVie) – Incorrect Barcode (2023)

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

FDAOct 17, 2023IN, OR• AbbVie Inc.

PCF-H190DL Colonovideoscope (Aizu Olympus) – repair defect (2023)

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

FDAOct 16, 2023FL, KY, MA +3 more• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

PCF-H190L Colonovideoscope (Aizu Olympus) – repair defect (2023)

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

FDAOct 16, 2023FL, KY, MA +3 more• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

GIF-HQ190 Videoscope (Aizu Olympus) – repair defect (2023)

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

FDAOct 16, 2023FL, KY, MA +3 more• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

Tracheostomy Care Kits (Medline) – sharp brush edge risk (2023)

The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.

FDAOct 16, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

GIF-H190 Videoscope (Aizu Olympus) – repair defect (2023)

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

FDAOct 16, 2023FL, KY, MA +3 more• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

Vitality Polyaxial Screw (Zimmer Biomet) – incorrect size marking (2023)

Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.

FDAOct 16, 2023Nationwide• Zimmer Biomet Spine Inc.

Nurse Kit (Medline) – sharp brush edge risk (2023)

The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.

FDAOct 16, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

CF-HQ190L Colonovideoscope (Aizu Olympus) – repair defect (2023)

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

FDAOct 16, 2023FL, KY, MA +3 more• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

Nursing Skills Kit (Medline) – sharp brush edge risk (2023)

The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.

FDAOct 16, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

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