Ethicon, Inc. recalls DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application

Recalled March 28, 2018 · FDA recall Z-1147-2018 · Ethicon

Hazard

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

Units

20,090 eaches (10,545 units)

Sold at

US Nationwide Distribution

Description

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

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

Manufacturer(s)

Ethicon, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →