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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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CAMC Memorial Hospital, 3200 MacCorkle Ave SE, Charleston, WV 25304, USA

Total all time reports:  1
Latest report: April 26, 2020 12:00 PM
CAMC employee tests positive for COVID-19, CAMC Memorial Hospital, 3200 MacCorkle Ave SE, Charleston, WV 25304, USA

CAMC employee tests positive for COVID-19

April 26, 2020 12:00 PM

“A CAMC hospital employee has tested positive for COVID-19. That employee was exposed in the community and did not work in a patient care area.

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

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Recent Interesting Reports

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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
- 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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“my fiancee was served this raw chicken burger at your restaurant. She noticed it was raw halfway through. Very upsetting and disgusting. See Less
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“Company name: Ridley Block Operations
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Reason of the recall: Elevated levels of copper
FDA Recall date: July 13, 2020
Recall details: No other products are affected Ridley Block Operations is voluntarily recalling Ultralyx® 12% Protei ... See Moren Sheep with batch number HB01679401. The product has been found to contain elevated levels of copper. With prolonged consumption, the affected product could potentially have adverse health effects on sheep, including reductions in daily gains, icterus, partially cirrhotic livers and hemoglobin-stained kidneys. Occasionally, death occurs in copper-toxic sheep.

This recall relates only to Ultralyx 12% Protein Sheep with the following batch numbers printed on the package:

- Product Name: Ultralyx 12% Protein Sheep
- Batch/Lot# : HB01679401
- Item No./Product No.: 24419
- Package Info.: 50# Block

Customers are asked to remove all product matching this batch number from distribution and inventory and discontinue feeding it immediately.

No other batch number or other Ridley Block Operations products are involved in this voluntary recall. Of the batch of twenty blocks included in the recall, two blocks remain in the marketplace.

Ridley Block Operations will continue to work closely with the Food and Drug Administration throughout the recall process. Our representatives are in direct communication with our customers to ensure the proper identification and removal of the impacted products.

Check the full recall details on fda.gov

Source: FDA
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July 6, 2020 4:00 PM

“Company name: Baxter International Inc.
Brand name: Granules
Product recalled: Metformin Hydrochloride Extended-Release Tablets USP, 750 mg
Reason of the recall: N-Nitrosodimethylamine (NDMA)
FDA Recall date: July 06, 2020
Recall details: Company Announcement Granules Pharmaceuticals, Inc., Cha ... See Morentilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit. Granules’ test results showed NDMA levels above the FDA acceptable limit in one (1) out of the twelve (12) batches distributed to the US market. All other batches continue to remain within the specifications. Out of abundance of caution Granules Pharmaceuticals, Inc. has decided to voluntarily recall all twelve (12) of the distributed lots within expiry of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg from the market. Granules Pharmaceuticals, Inc. has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date of this letter. Granules Metformin Hydrochloride Immediate-Release Tablets USP, 500 mg, 850 mg & 1000 mg and Metformin Hydrochloride Extended-Release Tablets USP, 500 mg are not affected by this recall. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The Metformin Hydrochloride Extended-Release Tablets USP, 750 mg lots subject to the recall is identified in the table below. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

June 11, 2020 1:00 PM

“Company name: Lupin Pharmaceuticals, Inc
Brand name: Lupin
Product recalled: Metformin Hydrochloride Extended-release Tablets
Reason of the recall: Detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 11, 2020
Recall details: Lupin Pharmaceuticals Inc. is voluntarily recalling Met ... See Moreformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Metformin Hydrochloride Extended-Release Tablets USP, 500mg is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in a bottle containing 60 tablets with NDC 68180-336-07. The affected lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg is included in below table:

- Product Name: Metformin Hydrochloride Extended-Release Tablets USP, 500mg

- NDC: 68180-336-07

- Lot Number: G901203

- Expiration Date: 12/2020

The product can be identified by the NDC and the lot number available on the side of the bottle label. Metformin Hydrochloride Extended-Release Tablets USP, 500mg was distributed nationwide in the USA to wholesalers, distributors, and mail order pharmacies.

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product lot. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 15, 2020 11:00 AM

“Company name: Summitt Labs
Brand name: KORE ORGANIC
Product recalled: Watermelon CBD oil tincture
Reason of the recall: Contains lead
FDA Recall date: May 15, 2020
Recall details: Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle ... See More, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation. As part of this investigation Summitt Labs had a sample from Batch #730 Lot #K018 tested at an ISO/IEC accredited lab. Lead results were 500 ppb (.5ppm), which is within the legal limits as defined by the State of Florida. However, based on the test from the Florida Department of Agriculture and Consumer Services, Summitt Labs initiated, and will complete, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Agriculture and Consumer Services.

Summitt Labs is an inspected and licensed facility under the Florida Department of Food and Agriculture and Consumer Services to produce products containing CBD but the Federal Food and Drug Administration does not consider CBD to be a legal drug or dietary supplement. Ingestion of KORE ORGANIC Watermelon CBD Oil Batch #730 Lot #K018 containing lead could result in high lead exposure. According to the Florida Department of Health, acute lead poisoning could have signs and symptoms including but not limited to; Pain, Muscle Weakness, Paresthesia, Abdominal Pain, Nausea, Vomiting, Diarrhea, Constipation, Poor appetite, Weight Loss, Symptoms associated with encephalitis, Metallic taste in the mouth, Shock, Hemolysis, and Kidney Damage. To this date, Summitt Labs has not had a call, complaint or report of any adverse effect from the use of this product.

The product labels states that benefits may include, Anxiety Relief, Pain Reduction, Mood Enhancer, Restful Sleep and may Alleviate Stress. The product is packaged in 30 milliliter bottles; which could come in 9 count displays in Kraft paper packaging. The affected Kore Organic Watermelon CBD Oil lots include Batch#730 Lot#K018. The Product can be identified by the Kore Organic Logo and Kraft Paper Packaging on the 30 milliliter bottle. The product was distributed nationwide by Wholesalers (I.E. Nirvana Kulture and North East Rally), Samples by Sales Personnel, Tradeshow Samples, and by Summitt Labs. Summitt Labs is notifying its distributors and customers by email, phone, and personal visits to ensure the return of all recalled product.

Consumers, distributors and retailers that have Kore Organic Watermelon CBD Oil Batch #730 Batch #K018, which is being recalled, should stop using the product. Any consumer with Lot #K018 Batch #730 should return this product to the place of purchase for a full monetary refund. If that is denied, please contact Summitt Labs at the above number for refund information and any other information regarding this recall.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Chicken from Costco is almost raw, Costco Wholesale, 16580 NW 59th Ave, Hialeah, FL 33014, United States

Costco Wholesale, 16580 NW 59th Ave, Hialeah, FL 33014, United States

May 6, 2020 9:35 PM

“Translation:
Honestly, I love Costco, and I'm not trying to put any employee in a bad light, especially in the chicken-rotisserie area. I have a picture of how red hot it is on a piece of ... See Morebtn-link" href="https://safelyhq.com/product/meat#scroll" title="Product: Meat">meat and blood on the bones. Chickens need more fire and cooking.

Original:
Con sinceridad, amo Costco, y no trato de poner en mal a ningun empleado en especial la zona de los asadores de pollo. Tengo la foto lo rojo vivo que esta en una parte de la carne y sangre en los huesos. Los pollos necesitan mas fuego y cocimiento. See Less
Reported By SafelyHQ.com User