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Showing 10701–10720 of 11714 results

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PHARMORIGINS CORE (Fusion Health) – unapproved additive (2020)

The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements

Class IIModerate

FDANov 17, 2020Nationwide• Fusion Health and Vitality LLC

Boston Scientific Corporation: Contour VL Variable Length Ureteral Stent, UPN M006180155...

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

FDANov 16, 2020Nationwide• Boston Scientific Corporation

Covidien Llc: Capnostream 35 Portable Respiratory Monitor, Product numb...

The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.

FDANov 16, 2020Nationwide• Covidien Llc

Medtronic Neuromodulation: Medtronic Intellis Spinal Cord Stimulator, Model Number A...

A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.

FDANov 12, 2020Nationwide• Medtronic Neuromodulation

Medtronic Inc.: CareLink Personal Software Therapy Management Software To...

Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.

FDANov 12, 2020Nationwide• Medtronic Inc.

Shimadzu Medical Systems: Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 V...

There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.

FDANov 9, 2020Nationwide• Shimadzu Medical Systems

Helena Laboratories, Corp.: K-ACT Actalyke Clotting Test Tubes that are used in the: ...

Due to complaints received associated with cracked/split test tube caps.

FDANov 9, 2020Nationwide• Helena Laboratories, Corp.

Exactech, Inc.: Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

FDANov 9, 2020CA, KS, OH• Exactech, Inc.

Fresenius Medical Care Holdings, Inc.: Citrasate Liquid Acid concentrate bottles, Model Number 0...

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

FDANov 7, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: NaturaLyte Liquid Acid concentrate bottles, Model Number ...

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

FDANov 7, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Cobalt Implantable Cardioverter Defibrillators with Cardi...

Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

FDANov 5, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Boston Scientific Corporation: EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSoni...

This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.

FDANov 3, 2020Nationwide• Boston Scientific Corporation

Respironics California, LLC: Philips Respironics V60 Plus Ventilator Part Number 11372...

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

FDANov 2, 2020Nationwide• Respironics California, LLC

Respironics California, LLC: Philips Respironics V680 Ventilator Part Number 850011 - ...

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

FDANov 2, 2020Nationwide• Respironics California, LLC

Respironics California, LLC: Philips Respironics V60 Ventilator Part Number 1053613 - ...

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

FDANov 2, 2020Nationwide• Respironics California, LLC

Luminex Corporation: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

Luminex Corporation: Verigene Clostridium difficile Nucleic Acid Test Kit (CDF...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

Luminex Corporation: Verigene Gram-Positive Blood Culture Nucleic Acid Test (B...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

Luminex Corporation: Verigene Enteric Pathogens Nucleic Acid Test (EP) Model N...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

Luminex Corporation: Verigene Gram Negative Blood Culture Nucleic Acid Test (B...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

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