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Showing 2181–2200 of 8389 results

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McKesson Calcium Alginate Dressing (Advanced Medical) – Packaging Sterility Issue (2024)

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

FDAOct 1, 2024Nationwide• Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom

Hollister CalciCare Dressing (Advanced Medical) – Packaging Sterility Issue (2024)

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

FDAOct 1, 2024Nationwide• Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom

Merlin@home Transmitter (Abbott) – Software Upgrade Failure (2024)

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

Moderate

FDAOct 1, 2024Nationwide• Abbott Medical

Medline Maxorb Extra Alginate Dressing (Advanced Medical) – Packaging Sterility Issue (2024)

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

FDAOct 1, 2024Nationwide• Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom

Merlin@home Transmitter with MerlinOnDemand (Abbott) – Software Upgrade Failure (2024)

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

FDAOct 1, 2024Nationwide• Abbott Medical

Z-800 Infusion System (Zyno Medical) – WiFi Software Compatibility (2024)

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

FDASep 30, 2024AL, FL, LA +5 more• Zyno Medical LLC

Access Cortisol Assay (Beckman Coulter) – Calibration Curve Error (2024)

The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.

FDASep 30, 2024Nationwide• Beckman Coulter, Inc.

Bard Marquee Biopsy Instrument Kit (Bard) – Needle Retention Defect (2024)

Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.

FDASep 30, 2024Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438

Precice Max Femur Implant (NuVasive) – Design and Manufacturing Issue (2024)

Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

FDASep 30, 2024FL, NV• NuVasive Specialized Orthopedics, Inc.

IMMULITE 2000 PSA Assay (Siemens) – High-Dose Hook Effect Issue (2024)

The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).

FDASep 30, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Flex Extenders (Westmed) – Connector Connection Force Problem (2024)

Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.

FDASep 27, 2024AK, CA, CO +27 more• Westmed, Inc.

AVOXimeter 1000E (Accriva) – Calibration Value Inaccuracy (2024)

Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

FDASep 27, 2024AZ• Accriva Diagnostics, Inc.

King LTSD Airway Kit (King Systems) – Pediatric Use Limitation (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

King LTSD Size 2.5 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

Duraform Dural Graft Implant (Integra) – Endotoxin Levels (2024)

Out of specification endotoxin levels.

FDASep 26, 2024Nationwide• Integra LifeSciences Corp.

King LTSD Size 1 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

King LTSD Size 0,1 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

King LTSD Size 2 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

Elekta Biopsy Needle Kit (Elekta) – Microscopic Debris (2024)

Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.

FDASep 25, 2024AZ, CA, FL +8 more• Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden

Monoject Insulin Syringe (Cardinal Health) – Incompatibility Risk (2024)

Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.

FDASep 25, 2024Nationwide• Cardinal Health 200, LLC

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