Recall Z-0953-2021— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2021-01-04, terminated 2023-11-29. It names 2 FDA 510(k) clearances: K152096, K100423. 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. Reason: Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach.
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-04
- Terminated
- 2023-11-29
- Firm location
- Somerville, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K152096 — DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
- K100423 — DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.