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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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9 Tampines Ave 2, McDonald's, Singapore 529731, Singapore

Total all time reports:  1
Latest report: April 20, 2020 12:00 PM
Another McDonald's employee with Covid-19, 9 Tampines Ave 2, McDonald's, Singapore 529731, Singapore

Another McDonald's employee with Covid-19

April 20, 2020 12:00 PM

“McDonald’s has closed its restaurant a “drive-thru” store at a Shell petrol kiosk along Tampines Ave 2 after two employees tested positive for Covid-19, bringing the total number of infected staff to seven.

Source: todayonline.com See Less
Reported By SafelyHQ.com User

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“Company name: Chengdu Ai Qin E-commerce Co., Ltd
Brand name: TTDeye
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Reason of the recall: Distributed without FDA clearance may pose health risk
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Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiate ... See Mored a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health. The company has received no complaints to date.

These colored contact lenses were sold through the company website and shipped directly to the customer from 08/05/2019 - 10/11/2019. The recalled products were manufactured in August 2018 and may be identified by name of the product and the date of manufacture, “2018-08”, found on the package label. The following products are being recalled:

- TTDeye. Black Starshine. Lot code: B16112100
- TTDeye. Diamonds Starlight. Lot code: B16112203
- TTDeye. Flower. Lot code: Brown. Lot code: B16112210
- TTDeye. Flower Grey. Lot code: B16112231
- TTDeye. Radial. Lot code: Brown. Lot code: B16112109
- TTDeye. Radial Pink. Lot code: B16112110
- TTDeye. Devil Red. Lot code: B16112201

If you have received this product, immediately cease use and contact the company via online chat at www.ttdeye.com between 9AM and 6PM (GMT+8) or contact the company via email at info@ttdeye.com (24 hours) for further information.

Chengdu Ai Qin E-commerce Co., Ltd is notifying its customers by email and is arranging for return/replacement of all recalled colored contact lenses.

Chengdu Ai Qin E-commerce Co., Ltd is voluntarily recalling these contact lenses after becoming aware of the problem. Chengdu Ai Qin E-commerce Co., Ltd has notified the FDA of this action.

Check the full recall details on fda.gov

Source: FDA
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“Company name: CME America
Brand name: CMEAmerica BodyGuard
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Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
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Recall ... See Moredetails: CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020). Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market.

The following is a summary of each individual product recall details:

CMEAmerica BodyGuard® Infusion Pump Recall

Details On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic: Use of products in the field in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter; Product service and repair activities at CME America and Authorized Service Depots; and Supply of infusion sets and accessories to support the infusion pumps remaining in the field.

The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
- BodyGuard 121
- BodyGuard 323
- BodyGuard 545*
- BodyGuard 575*
- BodyGuard 545 ColorVision
- BodyGuard 575 ColorVision
- CMExpress

*Note: These two pump models were inadvertently left out of the initial customer notification

CMEAmerica BodyGuard® Microset Infusion Set Recall

Details On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers. Affected products include:

CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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April 12, 2020 12:44 PM

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The FDA guidelines address 4 specific areas:
1) *Monitor Employee Health* - Management must instruct employees to speak up about possible COVID-19 symptoms or exposure and implement workplace controls to screen and reduce possible transmission. Workplace controls can include: Pre-screening employees for high temperatures, increase disinfecting and cleaning of workspaces and equipment, wearing personal protective equipment (PPE) such as face mask and gloves, and practicing social distancing of at least 6 ft when possible.
2) *Emphasize Personal Hygiene for Employees* - When working, employees must wash their hands with soap and water for at least 20 seconds especially after using the bathroom, before eating, and after blowing your nose, coughing, or sneezing. If soap is not available, employees must use an alcohol-based sanitizer with at least 60% alcohol. Employees should also avoid touching exposed food or surfaces with their bare hands and need to always wear gloves.
3) *Follow and Enhance Food Safety Protocols* - Food establishments must follow established food safety protocols such as cooking foods to the proper temperature and separating raw and cooked ingredients. In addition to standard safety protocols, establishments need to increase safety measures to help customers maintain infection prevention by encouraging spacing in lines, discontinuing salad bars and buffets, and discouraging bringing pets into stores.
4) *Manage Food Pick-Up and Delivery* - For food pick-up, establishments need to create protocols to allow customers to maintain social distancing and maintain food safety standards. FDA recommends the creation of designated pick-up zones to allow for customers to maintain proper social distancing. For delivery, no-contact delivery and customer communication via Text and calls should be enacted.

This is not a comprehensive list and is only best practice guidelines from the FDA. If you spot issues or violations, please report at https://safelyhq.com/tag/coronavirus-covid-19

To review the in-depth guidance from the FDA please go here: fda.gov

Source: FDA
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Reported By SafelyHQ.com User