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

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

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.

• 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.

• 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 call Mary Goldberg at 973-569-9000 x104 or email [email protected].
• DermaRite has notified its distributors and customers by e-mail 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 go to DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination | FDA

• 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  

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

• 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 response form via e-mail to [email protected] as soon as possible.
• If you need urgent assistance or replacement, contact SunMed directly.
• Notify all affected personnel in your organization of recall.

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

SUMMARY

The Office of Developmental Programs (ODP) is sharing this important announcement from the U.S. Food and Drug Administration (FDA) about the recall of Defibtech, LLC, RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions.

The use of the affected product may cause serious adverse health consequences, including

• patient injuries;
• delay of therapy;
• death due to a period of time without compressions to circulate oxygen throughout the body.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

• RMU-2000 Chest Compression Module
• Product Name: RMU-2000 ARM XR Chest Compression Device
• Unique Device Identifier (UDI)/: UDI-DI: 00815098020812, 10815098020819 
• Serial Numbers: See full list.

Do not use affected Defibtech RMU-2000 ARM XR Chest Compression Devices (identified by serial numbers).

On July 12, 2024, Defibtech, LLC, sent all affected customers an Urgent Medical Device Safety Removal letter recommending the following actions: 

• Identify and quarantine affected units.
• If devices were transferred or distributed further, please ensure the recipients are aware of this notice or provide Defibtech with contact information.

Customers will be contacted by Defibtech to arrange for product return and devices will be refunded, repaired, or replaced at no cost.

Defibtech, LLC, is recalling RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions.

The use of affected product may cause serious adverse health consequences, including patient injuries, delay of therapy and death due to a period of time without compressions to circulate oxygen throughout the body. There has been one reported injury and one report of death. 

The RMU-2000 ARM XR Chest Compression Device is used to provide chest compressions on adults whose hearts suddenly stop and are not circulating blood throughout the body.

Customers in the U.S. with questions about this recall should contact Defibtech Customer Support: 1-877-453-4507, 7:30AM - 6PM Eastern.