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Alert

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The Office of Developmental Programs (ODP) has shared this important announcement from the U. S. Food and Drug Administration (FDA).

The FDA is aware that Abbott Diabetes Care has sent all affected customers, distributors, and health care providers a letter regarding an issue with certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors providing incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.

As of November 14, 2025, Abbott has reported 736 serious injuries and seven deaths associated with this issue.

Affected Product

  • FreeStyle Libre 3 Sensor
    • Model Numbers: 72081-01, 72080-01
    • Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
  • FreeStyle Libre 3 Plus Sensor
    • Model Numbers: 78768-01, 78769-01
    • Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014
  • Download the full list of affected lots

What to Do:

Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s).

On November 24, 2025, Abbott Diabetes Care sent all affected customers a letter recommending the following actions:

  • For Patients:
    • Determine if your current or unused sensor(s) are affected by visiting FreeStyle Check and selecting “CONFIRM SENSOR SERIAL NUMBER.” You will need to locate your sensor serial number to determine if your sensor is affected.
      • If you are wearing a FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor, you can find the serial number in the app or reader. The serial number can also be found on the label on the bottom of the sensor applicator or carton. (If you are using a sensor with a connected insulin delivery device, please refer to the connected insulin delivery device user manual on how to locate the sensor serial number.)
    • If you are currently wearing or have a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affected on FreeStyle Check or by a customer service representative, immediately discontinue use and dispose of the affected sensor(s).
    • You can request a replacement for any potentially affected sensor(s) on FreeStyle Check. Select “CONFIRM SENSOR SERIAL NUMBER” and enter a valid serial number. If your sensor is potentially impacted, you will be instructed to enter your contact information so a replacement product can be sent to you at no cost.
    • Use a blood glucose meter or the built-in meter in your FreeStyle Libre 3 Reader to make treatment decisions when your sensor readings don’t match your symptoms or expectations.

Visit the FDA’s website for additional information and instructions on how to locate the Sensor’s Serial Number.

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The Office of Developmental Programs (ODP) has shared this important announcement from the U. S. Food and Drug Administration (FDA).

FDA MedWatch — DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products by DermaRite Industries

DermaRite Industries is recalling the below products due to microbial contamination identified as Burkholderia cepacia.

Risk Statement:

Burkholderia cepacia complex (BCC) in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals. In healthy individuals with minor skin lesions, the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into blood stream leading to life-threatening sepsis.

The recalled products were distributed nationwide in the United States and in Puerto Rico.

To date, DermaRite has not received any reports of adverse events related to this recall.

Background:

  • DermaKleen is an OTC Healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.
  • DermaSarra is an OTC External analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, sunburn.
  • KleenFoam is an OTC Antimicrobial foam soap with aloe vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.
  • PeriGiene is an OTC Antiseptic cleanser indicated for use in the perineal area.

Recommendations:

  • Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
  • Consumers with questions regarding this recall can contact Mary Goldberg at 973-569-9000 x104 or via email.
  • DermaRite has notified its distributors and customers by email to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.

For more information about this recall and specific product number, visit the FDA’s website.

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The Office of Developmental Programs (ODP) has shared an important announcement from the US Food and Drug Administration (FDA).

Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

SunMed Holdings, LLC is recalling this product due to a manufacturing issue where the B/V filter was assembled onto the patient port instead of the exhalation port. This incorrect configuration may result in a delay in therapy during emergency use.

The use of the affected product may cause serious adverse health consequences, including lack of oxygen to the body (hypoxia), build-up of carbon dioxide in the blood (hypercapnia), organ failure, and death.

There have been no reported injuries. There have been no reports of death.

Device Use

The manual resuscitator is used to provide emergency respiratory support to adult patients. It includes a face mask, bag reservoir, filter, manometer, and oxygen tubing, and is used during situations such as cardiac arrest or respiratory failure to manually deliver breaths.

Affected Product

  • Product Names: Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft. Oxygen Tubing
  • Unique Device Identifier (UDI)/Model: Each: 10884389164822, Case: 40884389164823
  • Lot/Serial Numbers: 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 26807, 526808, 526809, 526810, 526814, 526815, 526816, 526811, 526817, 526818

What to Do  

  • Stop using and quarantine all affected product immediately.
  • Document quantity on hand and arrange to return or destroy affected units.

On May 1, 2025, SunMed Holdings, LLC sent all affected customers an Urgent Medical Device Recall notice recommending the following actions:

  • Check your inventory for the affected product.
  • Stop using the product immediately and quarantine it.
  • Document the amount of product on hand and return or destroy affected units.
  • Distribute the recall notice to any customers who received the product from you.
  • Complete and return the response form via email as soon as possible.
  • If you need urgent assistance or replacement, contact SunMed directly.
  • Notify all affected personnel in your organization of recall.

Refer to the FDA Original Press Release for instructions on requesting a replacement and additional information.

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The Centers for Medicare & Medicaid Services (CMS) issued an alert about a fraud scheme that uses phishing fax requests, which falsely claim to be from CMS staff, to obtain medical records and documentation for auditing purposes.

CMS does not initiate audits by requesting medical records via fax, and if you receive a suspicious request, do not respond. If you have additional questions about this alert, please reach out to Karissa Bjorkgren of CMS via email.

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Immediate Action Required for Regulatory Compliance – Please Read Carefully

The Department of Human Services (DHS) is providing a critical update to those providers who hold a license to operate a facility licensed by DHS. On August 18, 2022, DHS and RCPA released an alert regarding changes in how licensed agencies provide information related to civil rights compliance. Since that time, DHS has received several questions and is providing further clarification.

  1. When sending the CRC form or the CRC attestation form, please send it as a PDF. Please do NOT send as a secure file, secure email, or link to a secure portal to retrieve the document. We are unable to access those forms, and they will be returned. When emailing the forms for submission:
    1. Use the following naming convention in the subject line when submitting Renewal HS2125:
      • Attestation – Program Office – Name of Facility or Agency – License number or APP number if assigned
        • Examples:
          • Attestation – OCYF – Apple Agency Home – 123450
          • Attestation – ODP – Apple Agency – APP-00123456
    2. Use the following naming convention in the subject line when submitting a new application HS2126:
      • New – Program Office – Type of Service – Name of Facility or Agency
        • Examples:
          • New – BHSL  – PCH – Apple Personal Care Home
          • New – ODP – Life Sharing – Apple Agency – APP-00223456
  2. In the Office of Developmental Programs (ODP) and the Office Mental Health and Substance Abuse Services (OMHSAS), there are providers who have one license that cover multiple locations. In this case, you only need to submit one form (either the HS2125 or the HS2126) and list the addresses of each satellite site/location that falls under that license.
  3. If in the past, you completed the Civil Rights Compliance Questionnaire (CRCQ) annually, as part of the renewal license process, you will need to complete the Civil Rights Attestation (HS2125) when you receive your next notice to complete the renewal application process.
  4. If you have a current license, your CRC was approved. You will need to complete the Civil Rights Attestation (HS2125) when you receive your next notice to complete the renewal application process.
  5. For Assisted Living and Personal Care Home providers, when submitting the renewal application for a license, the renewal application, the renewal application fee, and the Attestation (HS2125) must be sent in hard copy in one envelope to Licensing Administration in Harrisburg, as noted on the cover letter of the renewal application packet.
  6. Please ensure that the “Non-Discrimination in Employment” policy statement and the “Non-Discrimination in Services” policy statement issued by your facility contain updated contact information (as indicated below). If this administrative update is the only change that has occurred since the facility’s last license was issued, it is not necessary to provide updated copies to the Department as part of Form HS 2125.

Commonwealth of Pennsylvania
Department of Human Services
BEO/Office of Civil Rights Compliance
Room 225, Health & Welfare Building
P.O. Box 2675 Harrisburg, PA 17120
Inquiries: (717) 787-1127
Email

Office for Civil Rights
U.S. Department of Health and Human Services Centralized Case Management Operations 200 Independence Avenue, S.W.
Room 509F HHH Bldg
Washington, D.C. 20201
Customer Response Center: (800) 368-1019 TDD: (800) 537-7697

U.S. Equal Employment Opportunity Commission
801 Market Street, Suite 1000
Philadelphia, PA 19107-3126
Inquiries: (800) 669-4000
Complaint Process Overview

Pennsylvania Human Relations Commission
333 Market Street, 8th Floor
Harrisburg, PA 17101
Inquiries: (717) 787-4410

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The Pennsylvania Department of Drug and Alcohol Programs (DDAP) today issued Licensing Alert 02-22, which details the process for establishing mobile narcotic treatment programs (NTPs). In 2021, the Drug Enforcement Agency issued a final rule authorizing NTPs to add mobile components for dispensing controlled substances for maintenance or detoxification treatment without obtaining a separate registration.

Read the full DDAP Licensing Alert.

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