RSDL Reactive Skin Decontamination Lotion Kit recalled for leaking packets
Emergent Protective Products USA Inc recalls RSDL Decontamination Lotion Kits due to complaints of leaking packets. Approximately 4,000 units were distributed to Virginia, Canada, and Switzerland.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. Although no illnesses or injuries have been reported, the Class I status applies due to the defect's potential impact on a protective device intended for chemical decontamination.
Plain-English summary
The RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229, is designed to remove and neutralize chemical warfare agents and T-2 Toxin from the skin. The manufacturer, Emergent Protective Products USA Inc, has initiated a recall following complaints of leaking packets.
Approximately 4,000 units have been distributed. The affected lots are 23005060, 23005061, and 23005062. These kits were shipped to the state of Virginia (through a distributor), Canada, and Switzerland.
Recipients of affected kits should contact Emergent Protective Products USA Inc for further information and instructions regarding the recall.
The recalled product
- Product
- RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.
- Manufacturer
- Emergent Protective Products USA Inc
- Category
- Medical Device
- Hazard
- Affected units
- 4,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: 00817129020013
- Lot numbers: 23005060
- 23005061
- 23005062. (01)00817129020013 (10) 23005060 (17) 270718 (F5408ENG)
Distribution
Distributed in 1 state:
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