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DERMABOND ADVANCED recallZ-0953-2021 · Ethicon, Inc. · initiated Jan 4, 2021

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 Ethicon, 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

Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

FDA root cause category: Packaging process control

What the company is doing

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 [email protected] 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-

Recall details

Recall number
Z-0953-2021
Status
Terminated
Initiated by the company
Jan 4, 2021
Recalling firm
Ethicon, Inc.
Quantity
23,580 eaches
Product code
MPN
FDA submissions
K100423, K152096
Distribution
US Nationwide

Product description

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 (models, lots, serial numbers)

Lot Number: QEBBTQ Exp. Date: April 30, 2022 GTIN: 10705031203532

Devices named in this recall

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

Product lines

Sources and updates

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