Ethicon product recalled over laceration hazard

Recall date

November 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-1147-2018

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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