FDA recall Z-0953-2021

Ethicon, Inc. · Class II · device

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 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

Distribution

US Nationwide

Key facts

Status
Terminated
Initiation date
2021-01-04
Report date
2021-02-10
Termination date
2023-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0953-2021