TradepilotUSA
TradepilotUSA Recalls

TradePilot Recalls

Official product recall notices and clearly labeled enforcement reference records.

Reference notice · device

Steris Corporation — HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.

A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.

Mentor, OH, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Nihon Kohden America LLC — Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 0

Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.

Irvine, CA, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Steris Corporation — VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…

Mentor, OH, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Steris Corporation — VERIFY Biological Steam Test Pack Model/Catalog Number: S3069

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…

Mentor, OH, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Safeguard US Operating LLC — Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Drab, Stocked (Option 1)

Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.

Huntersville, NC, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Steris Corporation — VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…

Mentor, OH, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Beckman Coulter Inc. — DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13

Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configura…

Brea, CA, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Steris Corporation — VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…

Mentor, OH, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Beckman Coulter Inc. — DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520

Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configu…

Brea, CA, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Steris Corporation — VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…

Mentor, OH, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

Steris Corporation — VERIFY Biological Steam Test Pack Model/Catalog Number: S3065

Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not…

Mentor, OH, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

ASP Global, LLC. — Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable Product Description: S

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Austell, GA, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

ASP Global, LLC. — Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW Model/Catalog Number: 564009 Software Version: Not Applicable Product Description:

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Austell, GA, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

ASP Global, LLC. — Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Version: Not Applicable Product Description: Steril

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Austell, GA, US · Event · Updated

Source: FDA — device enforcement reference

Reference notice · device

ASP Global, LLC. — Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 Software Version: Not Applicable Product Description:

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Austell, GA, US · Event · Updated

Source: FDA — device enforcement reference
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