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Lake City, Florida, United States

Updated: September 12, 2023 7:52 PM
Marble, 678 192-14 Northern Blvd. Flushing, N.Y. 11358, I have been receiving NU-Glo Skin Care creams that I do not want. They were sent USPS Ground Advantage with a tracking number bar code. I would like to get them to stop sending these. See Less
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A package I didn’t order USPS tracking number 9400 136105155577******, I received a very small apple trinket to go in a chain I have not ordered anything similar! Please let me know what should have been in the package See Less
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Parts of Lake City are under a boil water notice.

The notice is in effect for SE Camp Street, starting at the intersection with SE Church Avenue and ending at the Hernando Avenue intersection.

Source: wcjb.com
Source publication date: 2021 11 10 See Less
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Employees are exposed to a COVID-19 infection hazard in that the employer is not adhering to the CDC COVID-19 Guidelines for preventing COVID-19 transmission, specifically: the employer has not sanitized work areas where COVID-19 positive employees have worked.

Alleged Hazards: 1, Employees Exposed: 100
Source: Osha.gov |... See More Receipt Date: 2021-08-16 See Less
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As the storm carried through the morning hours, the Clay Electric Outage Map accounted for as many as 6,000 without power.

Source: actionnewsjax.com See Less
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Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA... See More SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.

Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.

The list below contains the specific product and codes in scope.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode, Product Code: 0845, UDI-DI: 10614559103906.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode, Product Code: 0846, UDI-DI: 10614559104248.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode, Product Code: 0847, UDI-DI: 10614559104842.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode, Product Code: 0848, UDI-DI: 10614559104859.

Customers should review and follow the instructions provided in the December 2023 recall notification (link given below). Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.

Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Megadyne Medical Products, Inc.
Brand name: Megadyne
Product recalled: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
Reason for the recall: Limit use to patients aged 12 years or older.
FDA Recall date: February 29, 2024

Recall link of December 2023: jnjmedtech.com
Source: fda.gov
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