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Showing 4661–4680 of 8393 results

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Oculus Pentacam AXL Wave (Oculus) – Coating Measurement Risk (2023)

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

FDAAug 8, 2023Nationwide• Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany

Fresenius 3ML Syringe (Fresenius) – Leakage Potential (2023)

There is a potential for blood backfill leakage and foreign material.

FDAAug 8, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius 10ML Syringe (Fresenius) – Leakage Potential (2023)

There is a potential for blood backfill leakage and foreign material.

Moderate

FDAAug 8, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

ADVIA Chemistry Iron Reagents (Siemens) – QC Result Bias (2023)

There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.

FDAAug 8, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Prucka 3 Amplifiers (GE Medical) – Power Supply Failure (2023)

A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.

FDAAug 8, 2023CA, CO, FL +14 more• GE Medical Systems Information Technologies Inc

FX Shoulder Glenosphere (FX Shoulder) – Component Mismatch (2023)

Centered glenosphere box may contain an eccentric glenosphere.

FDAAug 8, 2023Nationwide• FX SHOULDER

Oculus Myopia Master (Oculus) – Coating Measurement Risk (2023)

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

FDAAug 8, 2023Nationwide• Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany

Oculus Pentacam AXL (Oculus) – Coating Measurement Risk (2023)

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

FDAAug 8, 2023Nationwide• Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany

B. Braun NORM-JECT Luer Lock (B. Braun) – Packaging Sterility (2023)

The sterile blister packaging may be damaged, and sterility may be compromised

FDAAug 7, 2023Nationwide• B. Braun Medical, Inc.

Stryker ACM Cement Mixing System (Stryker) – Nozzle Breakage Risk (2023)

Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site

FDAAug 7, 2023Nationwide• Stryker Corporation

B. Braun NORM-JECT Luer Solo (B. Braun) – Packaging Sterility (2023)

The sterile blister packaging may be damaged, and sterility may be compromised

FDAAug 7, 2023Nationwide• B. Braun Medical, Inc.

Heartmate 3 LVAS Kit (Thoratec) – Coring Knife Sharpness (2023)

Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.

FDAAug 7, 2023Nationwide• Thoratec Corp.

VITROS XT ALKP Slides (Ortho-Clinical) – Substrate Depletion (2023)

Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

FDAAug 5, 2023Nationwide• Ortho-Clinical Diagnostics, INc.

VITROS XT TBIL-ALKP Slides (Ortho-Clinical) – Substrate Depletion (2023)

Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

FDAAug 5, 2023Nationwide• Ortho-Clinical Diagnostics, INc.

Altivate Reverse Humeral Stem (DJO) – Sterilization Omission (2023)

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

FDAAug 4, 2023AL, AZ, CA +23 more

Hudson RCI Addipak (Medline) – Sterility Failure (2023)

Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.

FDAAug 4, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Reverse Shoulder System Socket Insert (DJO Surgical) – sterilization issue (2023)

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

FDAAug 4, 2023AL, AZ, CA +23 more

CLP Hip Stem (DJO Surgical) – sterilization issue (2023)

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

FDAAug 4, 2023AL, AZ, CA +23 more

Delta Ceramic Femoral Head (DJO Surgical) – sterilization issue (2023)

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

FDAAug 4, 2023AL, AZ, CA +23 more

Empowr Knee Baseplate (DJO Surgical) – sterilization issue (2023)

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

FDAAug 4, 2023AL, AZ, CA +23 more

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