FDA recall Z-1147-2018

Ethicon, Inc. · Class II · device

Product

DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound durinQ application of the liquid adhesive

Reason for recall

Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2017-11-27
Report date
2018-03-28
Termination date
2019-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1147-2018