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Artopolis Bakery, Cafe & Agora, S Halsted St, Chicago, IL, USA, Artopolis Bakery, Cafe & Agora, S Halsted St, Chicago, IL, USA
3 years ago
306 South Halsted Street, Chicago, 60661 Illinois, United States
Report date: Sep 17, 2020
2. City of chicago food service sanitation certificate
- comments: observed no city of chicago certified food manager on site during time of inspection while preparing and serving cooked chicken, sliced tomatoes, potatoes,dairy creamer, leafy greens, salmon etc. Instructed to provide at least one certified manager on site at all times with valid original certificate posted for public view. Priority foundation violation. 7-38-012. Citation issued.
16. Food-contact surfaces: cleaned & sanitized
- comments: observed ice machine a little dirty inside. Instructed to clean and sanitize and maintain.
16. Food-contact surfaces: cleaned & sanitized
47. Food & non-food contact surfaces cleanable, properly designed, constructed & used
- comments: observed prep table shelves with excessive dried debris in bakery prep area in basement. Must clean and maintain.
55. Physical facilities installed, maintained & clean
- comments: observed pooling water on floor near ice machine. Must remove to prevent pest breeding site.
56. Adequate ventilation & lighting; designated areas used
- comments: observed burned out light bulbs in basement storage near liquor room. Instructed to replace and maintain adequate lighting.
58. Allergen training as required
- comments: observed no allergen training certificate on site for city of chicago certified food manager. Instructed to meet requirement and maintain on site for review.
Source: chicago.gov
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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.
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- 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.
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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.
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Recall link of December 2023: jnjmedtech.com
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