Walmart Recalls Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones Due to Rare and Dangerous Bacteria; Two Deaths Investigated

[Shiloh]

Source: https://www.cpsc.gov/Recalls/2022/Wa...s-Investigated


Walmart Recalls Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones Due to Rare and Dangerous Bacteria; Two Deaths Investigated

Name of Product:
Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones
Hazard:
Tests conducted by the Centers for Disease Control and Prevention (CDC) determined that a bottle of the room spray contained the rare and dangerous bacteria Burkholderia pseudomallei which causes melioidosis, a condition that is difficult to diagnose and can be fatal. CDC has been investigating a cluster of four confirmed cases of melioidosis including two deaths in the U.S. Though the source of these four infections has not been confirmed by CDC, the bottle with the same type of bacteria was found in the home of one of the melioidosis decedents.


Remedy: Refund


Recall Date:
October 22, 2021
Units:
About 3,900


Recall Details

Description:
Washington, D.C. – Walmart is recalling about 3,900 bottles of Better Homes and Gardens-branded- Essential Oil Infused Aromatherapy Room Spray with Gemstones in six different scents due to the possible presence of a rare and dangerous bacteria and risk of serious injury and death.
The Centers for Disease Control and Prevention (CDC) tested a version of the product and determined that it contained the dangerous bacteria Burkholderia pseudomallei which causes melioidosis. CDC has been investigating a cluster of four cases of melioidosis in the U.S., including two deaths. Cases were reported in Kansas, Minnesota, Texas and Georgia, including a child fatality.
Samples taken by CDC from a bottle of the Better Homes and Gardens Lavender & Chamomile aromatherapy room spray in the home of the Georgia victim found the presence of these dangerous bacteria.
The aromatherapy room spray was sold at about 55 Walmart stores nationwide and online at walmart.com from February 2021 through October 2021 for about $4. “Better Homes and Gardens Aromatherapy,” is printed on the label on the front of the 5-ounce glass bottle. The aromatherapy was sold with a pump spray nozzle in the following scents and product numbers:
84140411420 Better Homes and Gardens (BHG) Gem Room Spray Lavender & Chamomile
84140411421 Better Homes and Gardens (BHG) Gem Room Spray Lemon and Mandarin
84140411422 Better Homes and Gardens (BHG) Gem Room Spray Lavender
84140411423 Better Homes and Gardens (BHG) Gem Room Spray Peppermint
84140411424 Better Homes and Gardens (BHG) Gem Room Spray Lime & Eucalyptus
84140411425 Better Homes and Gardens (BHG) Gem Room Spray Sandalwood and Vanilla

Walmart has stopped sale of the product. The product was made in India.
Consistent with CDC’s guidance, consumers are urged to:

1. Stop using this product immediately. Do not open the bottle. Do not attempt to throw away or dispose of the bottle.
2. Double bag the bottle in clean, clear zip-top resealable bags and place in a small cardboard box. Return the bagged and boxed product to a Walmart store.
3. Wash sheets or linens that the product may have been sprayed on using normal laundry detergent and dry completely in a hot dryer, bleach can be used if desired.
4. Wipe down counters and surfaces that might have been exposed to the spray with an undiluted disinfectant cleaner.
5. Minimize handling of the product and wash hands thoroughly after handling the bottle or linens. Wash hands thoroughly after removing gloves.
6. If you have used the product within the last 21 days and experience fever or other symptoms, seek medical care and tell your doctor about the product exposure. Your doctor may recommend that you get antibiotics (post exposure prophylaxis) to prevent infection.

See CDC’s news release at https://www.cdc.gov/media/releases/2...-bacteria.html and https://emergency.cdc.gov/han/.




Remedy:
Customers will also receive a $20 Walmart Gift Card upon return.
Consistent with CDC recommendations, consumers should immediately stop using the recalled room spray, double bag the bottle in clean, clear zip-top resealable bags, place it in a small cardboard box and return it to any Walmart store for a full refund. Do not open the bottle. Do not attempt to throw away or dispose of the bottle.
When handling the product or cleaning contaminated surfaces, please follow the CDC guidance below.




Incidents/Injuries:
CDC has been investigating a cluster of four cases of melioidosis in the U.S., including two deaths. Cases were reported in Kansas, Minnesota, Texas and Georgia, including a child fatality.




Sold At

The aromatherapy room spray was sold at about 55 Walmart stores nationwide and online at walmart.com from February 2021 through October 2021 for about $4.



Manufactured In:
India


Recall number:
22-007

[Emily]

Burkholderia pseudomallei is a Tier I Select Agent.

https://www.selectagents.gov/compliance/guidance/security-plan/section11f.htm

Security Plan Guidance:
Section 11(f) – Tier 1 Security


Section 11(f) – Tier 1 Security

Tier 1 select agents and toxins require additional security measures to be implemented including the addition of pre-access suitability assessments, extra access controls, and extra barriers. These extra measures are intended to safeguard Tier 1 select agents and toxins further from theft, loss, or release. The list of Tier 1 select agents and toxins includes:

• Bacillus anthracis
• Bacillus cereus Biovar anthracis
• Botulinum neurotoxins
• Botulinum neurotoxin producing species of Clostridium
• Burkholderia mallei
• Burkholderia pseudomallei
• Ebola virus
• Foot-and-mouth disease virus
• Francisella tularensis
• Marburg virus
• Rinderpest virus
• Variola major virus (Smallpox virus)
• Variola minor virus (Alastrim)
• Yersinia pestis

An effective security plan for Tier 1 BSAT describes how the requirements of the regulations are met. The security plan should also discuss who manages security control measures. This may include:

• How the entity manages access controls – This management may include keys, card keys, access logs, biometrics and other access control measures for each of the security barriers in the security plan. This may be accomplished by directly controlling or interacting with a service provider (e.g., a security guard company).
• Designating personnel to manage the entity’s security systems, including intrusion detection
• How the intrusion detection alarm code is managed (who has it, when it is changed)
• How the entity tests and manages the configuration of the system
• How the entity responds to an access control or intrusion detection failure (e.g., alarm)
• How the entity screens visitors

Section 11(f)(1) – Pre-Access Suitability Assessment

The entity must develop, implement, and describe in the security plan procedures for conducting a pre-access suitability assessment of persons who will have access to a Tier 1 select agent or toxin. See the Guidance on Suitability Assessments. Individuals must have a pre-access suitability assessment conducted before they are allowed access to Tier 1 select agents and toxins.
Section 11(f)(2) – Responsible Official Coordination with Other Safety and Security Professionals

Entities must describe procedures for how an entity’s Responsible Official (RO) will coordinate their efforts with the entity’s safety and security professionals to ensure security of Tier 1 select agents and toxins and share, as appropriate.
Ideally the entity’s RO, safety, and security professionals should meet on a regular or defined basis. This may be annually in conjunction with the security plan review, after a security incident, when there is a significant entity change that affects security, or in response to a threat. See Figure 1 for an example of the personnel who should be involved in creating a security plan for entities registered to possess or use Tier 1 BSAT.
Section 11(f)(3) – Ongoing Suitability Assessments

Describe procedures for the ongoing assessment of the suitability of personnel with access to a Tier 1 select agent or toxin. See the Guidance on Suitability Assessments. The procedures must include:

• Self-Reporting – Individuals should be trained on how to report any incidents or conditions that might impact their ability to safely have access to select agents and toxins and to safeguard them from theft, loss, or release.
• Peer-Reporting – Individuals should be trained on how to report incidents or conditions that might impact the ability of others to safely have access to select agents and toxins. Peer-reporting should be safe and anonymous and protect whistle-blowers from repercussion.
• Employee Training – All employees must be trained on the entity’s policies and procedures for reporting, evaluating, and corrective actions concerning suitability assessments. This type of training may include threat awareness, self- and peer-reporting, behaviors of concern, and suitability policies.
• Ongoing Suitability Monitoring – All individuals with access to Tier 1 select agents and toxins must undergo ongoing suitability monitoring. There are several ways to achieve this, including annual performance reviews, access reviews, and criminal record reviews.

Section 11(f)(4) – Security Enhancements

Entities that possess Tier 1 select agents and toxins must adhere to extra security enhancements, including access limitations, extra barriers, intrusion detection system, and visitation policies.
Section 11(f)(4)(i) requires the entity to limit access to a Tier 1 select agent or toxin to only personnel who have been approved by the HHS Secretary or APHIS Administrator, following a security risk assessment (SRA) conducted by the Attorney General, and have had an entity-conducted pre-access suitability assessment. Such individuals must also be enrolled in an ongoing suitability assessment program conducted by the entity.

• Make sure that only HHS or USDA approved individuals have access to Tier 1 BSAT.
• Conduct a pre-access suitability assessment before granting access.
• Enroll each individual to be given access to Tier 1 BSAT in an ongoing suitability assessment program

Access Outside Normal Business Hours

Section 11(f)(4)(ii) requires the entity to limit access to registered spaces outside of normal business hours. Only individuals who have been specifically approved by the RO, or his/her designee, may be allowed to access laboratories or storage facilities containing Tier 1 select agents and toxins outside of normal business hours.
Limit access to registered spaces outside of normal business hours. This does not mean that personnel cannot work outside these hours; however, they should get specific approval by the RO, or his/her designee, before doing so. The entity may choose to establish specific after-hours work policies. For example, the entity could establish a 2-person rule for work conducted after hours. This rule should consider, and implement, any necessary justification for after-hours work, such as 24 hour animal studies.
Security Barriers

Section 11(f)(4)(iv) of the select agent regulations requires a minimum of three security barriers safeguarding Tier 1 select agents and toxins against theft, loss, or release. A barrier is a physical structure designed to prevent unauthorized access. Cameras, security lighting, and IDS are not considered security barriers because, while they may monitor and detect unauthorized access, they cannot, by themselves, prevent access. These security barriers must be identified on the entity’s registration (Sections 5A and 6A of APHIS/CDC Form 1) and described in the security plan.

• Implement a minimum of three physical security barriers to safeguard Tier 1 select agent and toxins against theft, loss, or release.
• Intrusion detection systems do not count because they cannot actually prevent access.
• Identify the security barriers in the entity’s registration and describe them in the security plan.

Examples of Acceptable Security Barrier Implementations...

And so on...

[Pathfinder]

CDC Lab Testing Confirms Cause of Melioidosis Outbreak


Bacterial Strain in Aromatherapy Spray a Match to Strain in Four Patients
Press Release
For Immediate Release: Tuesday, October 26, 2021
Contact: Media Relations
(404) 639-3286

The Centers for Disease Control and Prevention (CDC) today confirmed that bacteria in a Better Homes & Gardens aromatherapy spray in a Georgia melioidosis patient’s home genetically matches the bacterial strains in the patient, and three other patients in Kansas, Minnesota, and Texas infected since March.

CDC announced Friday that a bottle of the BHG aromatherapy spray in “Lavender & Chamomile with Gemstones” scent had tested positive for Burkholderia pseudomallei, the bacteria that causes melioidosis. But the final step in the investigation, being reported today, was to confirm the DNA fingerprint of the bacteria in the spray and in the patients was the same. This allows CDC to confirm the spray or one of its ingredients caused the four melioidosis infections.

“When you think about the thousands of things people come in contact with around their homes, it’s remarkable we were able to identify the source and confirm it in the lab,” said Inger Damon, MD, PhD, director of CDC’s Division of High-Consequence Pathogens and Pathology. “CDC scientists and our partners found the proverbial needle in the haystack.”

With the Consumer Product Safety Commission (CPSC) and Walmart, CDC has contacted the manufacturer in India to determine whether ingredients from the implicated spray were used in any other products. CDC scientists are working to assess the extent of contamination in other bottles and whether other scents may also be contaminated. Since Friday, CDC testing of an additional bottle of the spray has tested positive for the bacteria.

Anyone who has a bottle of BHG Lavender & Chamomile Aromatherapy Spray with Gemstones or other scents in the same product line purchased from Walmart online or in these Walmart storesexternal icon between February and Oct. 21, 2021, should stop using it immediately and follow the steps listed on CDC’s website to safely return the product to Walmart. CPSC and Walmart recalled about 3,900 bottles of aromatherapy spray on Oct. 22. Walmart is offering consumers a refund and a $20 gift card for its return.

CDC emphasized that consumers should not pour the contents down the drain or throw the bottle in the trash. The bacteria that cause melioidosis does not normally live in soil and water in the United States. If the spray bottles end up in landfills, the bacteria could become established and cause future melioidosis cases in the U.S. CDC is working with Walmart to ensure the returned bottles are disposed of properly and safely.

For more information about the investigation, please visit the webpage on this cluster of illnesses and the Health Alert Network notice. You can also visit CDC’s main melioidosis webpage.

###
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESexternal icon

CDC works 24/7 protecting America’s health, safety and security. Whether disease start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

Page last reviewed: October 26, 2021
Content source: Centers for Disease Control and Prevention

https://www.cdc.gov/media/releases/2021/p1026-melioidosis-outbreak.html

[sharon sanders]

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