Class 2 Device Recall Stimulen Collagen Lotion

• Date Initiated by Firm: May 28, 2021
• Create Date: July 21, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2109-2021
• Recall Event ID: 88163
• 510(K)Number: K030774
• Product Classification: Dressing, wound, collagen - Product Code KGN
• Product: Stimulen Collagen Moisturizing Lotion, ST9555B
• Code Information: Lot 2104007, EXP: 02/2024
• Recalling Firm/ Manufacturer: Southwest Technologies Inc; 1746 E Levee St; Kansas City MO 64116-4404
• For Additional Information Contact: Cindy Belt; 816-221-2442
• Manufacturer Reason for Recall: Dose audit failure after sterilization process
• FDA Determined Cause: Under Investigation by firm
• Action: The firm notified its sold consignee of the issue by telephone on 05/28/2021 of the issue. The firm followed with a letter disseminated by letter on 06/18/2021 requesting that the distributor destroy any product on hand and notify their customers.
• Quantity in Commerce: 2016 units
• Distribution: Malaysia
• 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 = KGN