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Showing 9601–9620 of 35916 results

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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.

Moderate

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.

AuDX PRO 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 Screening (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

Angiographic Catheter Sets (Cordis) – Non-Sterile Distribution (2023)

Non-sterile product labeled as sterile was distributed.

FDASep 26, 2023OK• Cordis US Corp

2-Port 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.

RapidPoint 500 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

Grafton DBM Flex (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

AMO Administration 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.

Allergan Universal Fill Kit (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.

Gastroscope (Aizu Olympus) – Channel Drying Issue (2023)

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

FDASep 25, 2023Nationwide• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

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