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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.

High

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

Mobile Airway Scope (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

Ureteralscope (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

Cystonephroscope (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

Sigmoidovideoscope (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

Small Intestinal Videoscope (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

Transnasal Esophagovideoscope (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

RSP Humeral Socket Insert (Unknown) – Device Swap Risk (2023)

Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.

FDASep 25, 2023CA, FL, IN +10 more

Tracheal Fiberscope (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

Colonoscope (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

Insufflation Unit (Olympus) – Air Supply Stoppage (2023)

Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".

FDASep 25, 2023Nationwide• Olympus Corporation of the Americas

Rhinolaryngoscope (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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