Class 1 Device Recall RSDL

• Date Initiated by Firm: November 24, 2022
• Date Posted: January 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0773-2023
• Recall Event ID: 91336
• 510(K)Number: K023969
• Product Classification: Decontamination kit - Product Code MAC
• 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.
• Code Information: UDI-DI: 00817129020013, Lot numbers: 23005060, 23005061, 23005062. (01)00817129020013 (10) 23005060 (17) 270718 (F5408ENG)
• Recalling Firm/ Manufacturer: Emergent Protective Products USA Inc; 46 Shelby Thames Dr; Hattiesburg MS 39402-3702
• For Additional Information Contact: Assal Hellmer; 240-631-6381
• Manufacturer Reason for Recall: Complaints of leaking packets were received.
• FDA Determined 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, bsadler@ebsi.com, 204-396-3815"
• Quantity in Commerce: 4000 units
• Distribution: Distribution to US state of VA (distributor), Canada, and Switzerland
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MAC and Original Applicant = DEPT. OF THE ARMY