Class 2 Device Recall Ethicon

• Date Initiated by Firm: January 04, 2021
• Create Date: February 04, 2021
• Recall Status: Terminated on November 29, 2023
• Recall Number: Z-0953-2021
• Recall Event ID: 87088
• 510(K)Number: K100423 K152096
• Product Classification: Tissue adhesive for the topical approximation of skin - Product Code MPN
• Product: Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12
• Code Information: Lot Number: QEBBTQ Exp. Date: April 30, 2022 GTIN: 10705031203532
• Recalling Firm/ Manufacturer: Ethicon, Inc.; Us Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: SAME; 908-218-0707
• Manufacturer Reason for Recall: Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
• FDA Determined Cause: Packaging process control
• Action: Ethicon issued Urgent Medical Device Removal Letter on 1/4/21 via UPS second day. Receipt of the letter will be confirmed via UPS tracking. Letter states reason for recall, health risk, action to take: 1.Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email it to Stericycle at 866-853-2807 or Ethicon5582@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 6. Customers are required to return unused impacted Dermabond Advanced" Topical Skin Adhesive subject to this recall that are in their inventory immediately. To receive replacement reimbursement, customers must return product subject to this recall no later than April 9, 2021. Any non-affected product and any product returned after the date specified will not receive replacement. 7. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling 800-
• Quantity in Commerce: 23,580 eaches
• Distribution: US Nationwide
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MPN