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McAlister's Deli

Updated: December 30, 2021 12:00 PM
1. Employees that tested positive for COVID-19 are required to come back to work.

Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-08-23 See Less
16


Multiple employees(2) at MC ALISTER'S DELI in CARLSBAD, NM tested positive for Covid-19 and the company is on the Rapid Response COVID-19 Watchlist Event Date: 08/18/2021,

Source: env.nm.gov See Less
10


Two managers have tested positive for Covid-19 and it has been rumored that several general employees have also contracted Covid-19. Management failed to inform employees that had been in close contact with the two confirmed cases and failed to tell anyone in the store besides other managers.... See More One manager tested positive early last week and has been at home since, but the second waited to be tested until later that week and the test came back positive.

Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-10-12
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204


Employees are being asked to lie on the health screening. Employer is not mandating masks. Employees are not notified of being in close contact with those who have or have had symptoms of COVID-19. Employer is telling employees exhibiting COVID-19 symptoms to continue working.


Source: Osha.gov |... See More Receipt Date: 2020-12-14 See Less
127


Multiple employees(2) at MC ALISTER'S DELI in ALBUQUERQUE, NM tested positive for Covid-19 and the company is on the Rapid Response COVID-19 Watchlist Event Date: 12/09/2020,

Source: env.nm.gov See Less
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3 confirmed employees have corona and counting. They will not close down establishment or take any extra precautions.


Source: Osha.gov | Receipt Date: 2020-07-08 See Less
127


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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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