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Showing 4381–4400 of 8389 results

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Denture Cleanser (Family Dollar) – Temperature Storage Issue (2023)

Products were stored outside of labeled temperature requirements.

FDAOct 4, 2023AL, AZ, AR +21 more• Family Dollar Stores, Llc.

Marijuana Test Strip (Family Dollar) – Temperature Storage Issue (2023)

Products were stored outside of labeled temperature requirements.

FDAOct 4, 2023AL, AZ, AR +21 more• Family Dollar Stores, Llc.

TruWave Pressure Monitoring Set (Edwards Lifesciences) – Flushing Difficulty (2023)

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Moderate

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Veradius Unity C-arm (Philips) – Puerto Rico Delivery Issue (2023)

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

FDAOct 4, 2023Nationwide• Philips North America

TruWave Pressure Monitoring Set (Edwards Lifesciences) – Flushing Difficulty (2023)

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Blood Uric Acid Monitoring System (Visgeneer) – Unapproved Distribution (2023)

Due to products distributed without premarket clearance or approvals.

FDAOct 4, 2023Nationwide• Visgeneer, Inc. No. 335 Zhong Hua Rd., Sec. 6 Xiangshan Dist. Hsinchu City Taiwan

Teeth Whitening Pen (Family Dollar) – Temperature Storage Issue (2023)

Products were stored outside of labeled temperature requirements.

FDAOct 4, 2023AL, AZ, AR +21 more• Family Dollar Stores, Llc.

FloTrac Sensor (Edwards Lifesciences) – Flushing Difficulty (2023)

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Acumen IQ Sensor with VAMP (Edwards Lifesciences) – Flushing Difficulty (2023)

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Clearblue Pregnancy Test (Family Dollar) – Temperature Storage Issue (2023)

Products were stored outside of labeled temperature requirements.

FDAOct 4, 2023AL, AZ, AR +21 more• Family Dollar Stores, Llc.

Tina-quant D-Dimer Test (Roche) – Result Elevation Issue (2023)

Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

FDAOct 3, 2023Nationwide• Roche Diagnostics Operations, Inc.

STAT-Site M BHB Test Strips (Unknown) – Performance Degradation (2023)

Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.

FDAOct 2, 2023Nationwide

ACMI Roller Bar Electrodes (Olympus) – Incorrect Pouch Labeling (2023)

Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

FDAOct 2, 2023AL, FL, GA +10 more• Olympus Corporation of the Americas

Coapt ControlSeal Electrode (Coapt) – Burn/Blistering Risk (2023)

Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

FDAOct 2, 2023Nationwide• Coapt LLC

Coapt Dome Electrode (Coapt) – Burn/Blistering Risk (2023)

Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

FDAOct 2, 2023Nationwide• Coapt LLC

Edge Biologicals Sterile Water (Edge Biologicals) – Packaging Mislabeling (2023)

Due to product outer packaging incorrectly labeled.

FDAOct 2, 2023Nationwide• Edge Biologicals Inc

EVIS EXERA III Videoscope (Olympus) – Sterilization Failure (2023)

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

FDAOct 2, 2023Nationwide• Olympus Corporation of the Americas

DRX Revolution X-Ray System (Carestream) – Electrical Component Failure (2023)

Unexpected failure of electrical components within the CPI generator.

FDAOct 2, 2023Nationwide• Carestream Health, Inc.

DRX-Revolution Mobile X-Ray (Carestream) – Generator Failure Risk (2023)

There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.

FDAOct 2, 2023Nationwide• Carestream Health, Inc.

EVO+VISIAN Lens (Staar Surgical) – Specification Concerns (2023)

Their is a potential that intraocular implant devices may not meet specifications.

FDASep 29, 2023AZ, AR, CA +35 more• Staar Surgical Company

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