Recall Z-0953-2021 ยท MPN Tissue Adhesive For The Topical Approximation Of Skin
Ethicon, Inc.
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
| Date | Jan 4, 2021 |
| Status | Terminated |
| Reason | Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach |
| Root 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 fac |
| Quantity | 23,580 eaches |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |