RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfar
Summary
The FDA issued a Class I for RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to by Emergent Protective Products USA Inc. Reason: Complaints of leaking packets were received..
Details
Source
Device Recall
External ID
Z-0773-2023
Action Date
2023-01-18
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: UDI-DI: 00817129020013, Lot numbers: 23005060, 23005061, 23005062. (01)00817129020013 (10) 23005060 (17) 270718 (F5408ENG)
Quantity Affected: 4000 units
Reason for Recall
Complaints of leaking packets were received.
Distribution
Distribution to US state of VA (distributor), Canada, and Switzerland
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-24
Company
Hattiesburg, MS
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Emergent Protective Products USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Emergent Protective Products USA Inc have FDA actions?
This is the only FDA action we have on record for Emergent Protective Products USA Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0773-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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