The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Emergent RSDL (Reactive Skin Decontamination Lotion) Kits
- Product Batch Number: 23005060
- Distribution Dates: October 4, 2022 to October 14, 2022
- Devices Recalled in the U.S.: 3,500
- Date Initiated by Firm: November 24, 2022
The RSDL (Reactive Skin Decontamination Lotion) kit is an easy-to-open packet containing a sponge soaked with lotion. The RSDL kit is carried by members of the military and is intended to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.
Reason for Recall
Emergent is recalling RSDL (Reactive Skin Decontamination Lotion) kits from a specific batch after customers noted that some packets were leaking. Product in leaking packets may not perform as effectively as intended. The leak in the package could cause the lotion-bearing sponge to dry out or lose lotion content. This may reduce the effectiveness of the kit. Users also may be unnecessarily exposed to the lotion if the package is leaking.
In a situation of exposure to chemical warfare agents or T-2 toxin requiring immediate decontamination with RSDL, the potential for reduced or absent device effectiveness could make the exposed individual vulnerable to health hazards from the chemical agent exposure. Additionally, unnecessary exposure to the non-opened packets that have been contaminated by the lotion from the leaked packets could result in unintentional prolonged skin, eyes, and mucous membrane exposure to the military personnel as well as unsuspecting handlers of the subject RSDL kits.
Use of the affected kits may lead to serious injury and/or death.
There have been 3 complaints and no reports of injuries or deaths related to this issue.
Who May be Affected
- Organizations who distribute RSDL kits to their personnel
- Personnel (including military personnel) who carry RSDL kits in case of exposure to chemical agents
What to Do
On November 2, 2022, Emergent sent customers an Urgent Recall Notification letter about this issue. The company recommended the following actions:
- Quarantine product from the identified batch (23005060)
- Hold product—cease distribution or use of the affected batches.
- Complete the response form and return as soon as possible.
- Identify and notify any customers who may have received further distribution of this product.
The company also noted that follow up communications will provide additional detail about how to manage product from the impacted batch.
Customers with questions about this recall should contact Emergent's RSDL Customer Service at 1-888-773-3266 or CustomerService@ebsi.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.