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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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Copeland Oaks, 800 S 15th St, Sebring, OH 44672, USA

Total all time reports:  1
Latest report: May 5, 2020 12:00 PM
48 retirement community residents has tested positive for COVID-19., Copeland Oaks, 800 S 15th St, Sebring, OH 44672, USA

48 retirement community residents has tested positive for COVID-19.

May 5, 2020 12:00 PM

“48 Crandall Medical Center on the campus of Copeland Oaks Retirement Community has reported positive for the COVID-19.

Source: salemnews.net See Less
Reported By SafelyHQ.com User

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April 29, 2020 7:00 PM

“Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
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
FDA Recall date: April 29, 2020
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
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- BodyGuard 575*
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- 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

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“Company name: PGG/HSC Feed Company, LLC, dba CHS Nutrition
Brand name: CHS Inc.
Product recalled: Champion Meat Goat Pellets R20, Medicated Feed
Reason of the recall: Due to elevated level of Rumensin ... See More(monensin)
FDA Recall date: May 29, 2020
Recall details: PGG/HSC Feed Company, LLC, dba CHS Nutrition of Hermiston, Oregon, is recalling 510 bags (50 lbs. each) of Champion Meat Goat Pellets R20, Medicated Feed due to elevated level of Rumensin (monensin). Monensin is an FDA-approved drug for use in certain animal feeds. However, if the feed contains excessive amounts, the feed can cause monensin toxicity in a number of animal species including goats. Goats ingesting excessive levels of monensin in feed are susceptible to injury and death. In goats, signs and symptoms can include bloated stomach, bloody urine, shortness of breath, muscle weakness or cramps, rapid breathing and death. In humans, monensin could affect handlers of highly concentrated products by causing irritation of the skin, eyes, and respiratory tract through direct exposure.

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Check the full recall details on fda.gov

Source: FDA
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Consumers who have a food allergy or have any sensitivity to milk or soy should not consume the product as it could result in a serious or life-threatening allergic reaction.

The recalled Lindt Excellence 85% Cocoa chocolate bars are labeled with Lot Code L5539, a Best Before date of 11-30-2020, and UPC of 3746601645.

For more information go here: fda.gov

Source: FDA
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