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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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Wisconsin Cheese Group, 105 3rd St, Monroe, WI 53566, USA

Total all time reports:  1
Latest report: May 5, 2020 12:00 PM
Six food plant workers have tested positive for COVID-19., Wisconsin Cheese Group, 105 3rd St, Monroe, WI 53566, USA

Six food plant workers have tested positive for COVID-19.

May 5, 2020 12:00 PM

“Six food plant workers at Wisconsin Cheese Group's packaging facility have tested positive for COVID-19.

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

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“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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Reported By SafelyHQ.com User

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“Company name: UVT, INC.
Brand name: Saniderm
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Reason of the recall: Potential presence of methanol (wood alcohol)
FDA Recall date: June 29, 2020
Recall details: UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED H ... See MoreAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) To date, UVT, INC. has not received any reports of adverse events related to this recall.

The affected SANIDERM ADVANCED HAND SANITIZER includes lot number 0530, Expiration date 04/2022. The product can be identified by the label below. The product was distributed Nationwide in the United States. The product is used as a hand sanitizer and is packaged in 1-liter plastic bottles.

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UVT, INC. is notifying its distributors and customers by phone calls, emails and letter and is arranging for replacement and destruction of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using products, initiate recalls to the user level, and return all products to the place of purchase.

Consumers with questions regarding this recall can contact UVT, INC. by phone (951) 427- 3108 or e-mail to customerservice@uvt.world Monday to Friday from 9:00 am and 3:00 pm Pacific Time. 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. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 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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Reported By SafelyHQ.com User

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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

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May 26, 2020 9:34 PM

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Raw Salmon, Applebee's, Rainbow Boulevard, Kansas City, Kansas, USA

Symptoms: Other
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December 21, 2019 1:38 PM

“Me and my boyfriend went to there and ordered salmon off the 2 for 30 offer the salmon was cooked on the ... See Moreoutside but raw on inside the waiter immediately came and took the plate and gave us their mangers card in case we ended up at the hospital. This happened Dec 20 2019 See Less
Reported By SafelyHQ.com User

June 18, 2020 11:00 PM

“Company name: GSK Consumer Healthcare
Brand name: Robitussin
Product recalled: Cough and cold products
Reason of the recall: Incorrect dosing cups
FDA Recall date: June 18, 2020
Recall details: GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Ch ... See Moreildren's Robitussin® Honey Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children's Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children's Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use). Children's Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children's Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults.

Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behaviour; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention.

As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product. The recall is limited to the three lots listed below:

Children's Robitussin® Honey Cough and Chest Congestion DM (4oz)
NDC 0031-8760-12
Lots: 02177 (Exp. Jan. 2022) / 02178 (Exp. Jan. 2022)

Children's Dimetapp® Cold and Cough (8oz)
NDC 0031-2234-19
Lot: CL8292 (Exp. Sep. 2021)

These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Wholesalers, distributors and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately.

Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. In December 2018, GlaxoSmithKline plc reached an agreement with Pfizer, Inc. to combine their consumer health businesses into a new Joint Venture. August 01, 2019 was the first day of the new GSK Consumer Healthcare Joint Venture. Thus, when identifying impacted product, please be aware the Pfizer company name will still be present on the label.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User