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Showing 4461–4480 of 22584 results

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Tracheal Intubation Fiberscope (Olympus) – Flow Rate Issue (2023)

Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

FDASep 28, 2023Nationwide• Olympus Corporation of the Americas

StealthStation S8 (Medtronic) – Surgical Data Shift (2023)

Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

FDASep 27, 2023Nationwide• Medtronic Navigation, Inc.

Journey II BCS Insert (Smith & Nephew) – Labeling Mixup (2023)

The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

Moderate

FDASep 27, 2023Nationwide• Smith & Nephew, Inc.

EXALT Duodenoscope (Boston Scientific) – Image Quality Problem (2023)

Poor image quality due to fluid ingress in the lens.

FDASep 27, 2023Nationwide• Boston Scientific Corporation

Journey II BCS Insert (Smith & Nephew) – Labeling Mixup (2023)

The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

FDASep 27, 2023Nationwide• Smith & Nephew, Inc.

Micro Spike Adapter (B. Braun) – Potential Leakage Risk (2023)

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

TheraSphere Admin Set (B. Braun) – Potential Leakage Risk (2023)

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

Grafton Plus DBM Paste (Medtronic) – Packaging Inspection Issue (2023)

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

FDASep 26, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Burette Assembly (B. Braun) – Potential Leakage Risk (2023)

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

SENTIERO Medical Device (PATH) – Technical Distortion (2023)

Affected lots of product may experience technical distortions to a greater extent than expected.

FDASep 26, 2023FL, MO, OH +1 more• PATH Landsberger Str. 65 Germering Germany

SENTIERO Screening2 (PATH) – Technical Distortion (2023)

Affected lots of product may experience technical distortions to a greater extent than expected.

FDASep 26, 2023FL, MO, OH +1 more• PATH Landsberger Str. 65 Germering Germany

Grafton DBM Orthoblend (Medtronic) – Packaging Inspection Issue (2023)

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

FDASep 26, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Grafton DBM Crunch (Medtronic) – Packaging Inspection Issue (2023)

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

FDASep 26, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Fluid Transfer Set (B. Braun) – Potential Leakage Risk (2023)

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

RapidPoint 500e System (Siemens) – Drug Interference Risk (2023)

There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.

FDASep 26, 2023Nationwide• Siemens Healthcare Diagnostics Inc

Terumo Tube Set (B. Braun) – Potential Leakage Risk (2023)

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

Grafton DBM Putty (Medtronic) – Packaging Inspection Issue (2023)

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

FDASep 26, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Grafton DBM Matrix Strips (Medtronic) – Packaging Inspection Issue (2023)

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

FDASep 26, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Grafton DMB Matrix (Medtronic) – Packaging Inspection Issue (2023)

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

FDASep 26, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Large Bore Male Fitting (B. Braun) – Potential Leakage Risk (2023)

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

FDASep 26, 2023Nationwide• B. Braun Medical, Inc.

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