Class 2 Device Recall 3M Tegaderm

• Date Initiated by Firm: August 14, 2024
• Date Posted: October 09, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0038-2025
• Recall Event ID: 95273
• 510(K)Number: K063458 K080620 K123679 K153410 K171908 K200835
• Product Classification: Dressing, wound, drug - Product Code FRO
• Product: 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
• Code Information: UDI/DI 10707387802223 (carton), UDI/DI 30707387802227 (each), Lot Number 33WWRRR
• Recalling Firm/ Manufacturer: 3M Company - Health Care Business; 3m Center 2510 Conway Ave; Bldg 275-5w-06; Saint Paul MN 55144-0001
• For Additional Information Contact: Lissa Reitz; 651-269-6250
• Manufacturer Reason for Recall: Contamination with foreign substance matter
• FDA Determined Cause: Under Investigation by firm
• Action: 3M notified its sole consignee (a distributor) on 08/14/2024 via email. The notice explained the issue and requested the following: Identify and discontinue distribution of affected product, notify those to whom you distributed the product, and return the product to the seller. The firm provided a letter for the distributor to send to its customers.
• Quantity in Commerce: 10,000 units
• Distribution: International distribution to the country of South Korea.
• 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 = FRO; 510(K)s with Product Code = FRO