Z-0773-2023Class I

RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize...

Name: Z-0773-2023 RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize...
Creator: Emergent Protective Products USA Inc
Published: 2022-11-24
License: https://open.fda.gov/license/

Serb Medical Solutions Inc. / initiated 2022-11-24 / Terminated / root cause: packaging

FDA source

Emergent Protective Products USA Inc began a recall of 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 on 2022-11-24. FDA classified it as Class I and gives the reason as "Complaints of leaking packets were received". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0773-2023
Classification: Class I
Status: Terminated
Initiated: 2022-11-24
Posted: 2023-01-10
Terminated: 2024-10-07
Recalling firm: Serb Medical Solutions Inc.
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.
Product code: MAC Decontamination Kit
Reason for recall: Complaints of leaking packets were received.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Emergent sent a RECALL NOTIFICAITON LETTER to its consignees by email on 11/24/2022. The notice explained the issue and requested that the consignee immediately hold the product and notify the firm if any product was forwarded to another organization for further distribution. The email response form provided self inspection instructions and to segregate failed packets and store them in a quarantine location to prevent distribution. Further information and materials were provided to return defective product to Emergent. Packets that have passed inspection criteria can be placed back into active inventory A follow up email recall communication was issued on 12/02/2022 as follows: "Reason for this Additional Notification: To provide information for product replacement and return. To provide information on Sub-Recall procedures. There is potential that packets that have passed visual inspection may have a seal that could be compromised under the certain conditions. These packets will be replaced with new product. In the interim period prior to receipt of new product, the packets that have passed your visual inspection can remain in your hold inventory. Instructions: Please follow the following steps: Complete actions as per the initial notification letter provided on 24 NOV 2022. After the completion of the visual inspection, packets that have passed should be placed into hold inventory. Receive replacement product. As soon as available, Emergent will ship new product to replace the entire initial shipment of the batch associated with the recall. Once the new inventory is received, all remaining packets from the recalled batch (Passed and Failed) should be returned to Emergent. Initiate Sub-Recalls to all customers you have distributed product to. Should you have any questions regarding this product recall, please contact: Brent Sadler, Sr. Director, Quality, [email protected], 204-396-3815"
Quantity in commerce: 4000 units
Distribution: Distribution to US state of VA (distributor), Canada, and Switzerland
Product codes and lots: UDI-DI: 00817129020013, Lot numbers: 23005060, 23005061, 23005062. (01)00817129020013 (10) 23005060 (17) 270718 (F5408ENG)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0773-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0773-2023	Class I	Terminated	Voluntary: Firm initiated	2023-01-18	2023-01-10

Product code MAC

K023969Class IReactive Skin Decontamination LotionDept. of the Army / cleared 2003-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)