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RSDL (Reactive Skin Decontamination Lotion) Kit, NSN… recallZ-0773-2023 · Emergent Protective Products USA Inc · initiated Nov 24, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Emergent Protective Products USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Complaints of leaking packets were received.

FDA root cause category: Packaging change control

What the company is doing

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"

Recall details

Recall number
Z-0773-2023
Status
Terminated
Initiated by the company
Nov 24, 2022
Posted by the FDA
Jan 10, 2023
Recalling firm
Emergent Protective Products USA Inc
Quantity
4000 units
Product code
MAC
FDA submissions
K023969
Distribution
Distribution to US state of VA (distributor), Canada, and Switzerland

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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