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Recall Observatory FDA recall evidence

Device 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.

Z-0773-2023

November 24, 2022

Class I

Product summary

Firm
Emergent Protective Products USA Inc
Event
Event 91336
Status
Terminated
Classification
Class I
Quantity
4000 units
Official record key
device-enforcement:Z-0773-2023

Official wording

Reason: Complaints of leaking packets were received.

Code information: UDI-DI: 00817129020013, Lot numbers: 23005060, 23005061, 23005062. (01)00817129020013 (10) 23005060 (17) 270718 (F5408ENG)

Distribution pattern: Distribution to US state of VA (distributor), Canada, and Switzerland

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints of leaking packets were received.