Reported Mar 28, 2018 · Terminated
DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only…
Ethicon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, Inc. · Us Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- DERMABOND" PRINEO"
- Skin Closure System Product UsageDERMABOND 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
- Lot codes and dates
LEJ230LEJ246LEJ259LEJ368LGP375LGP605LGP606LGP675LGP814LGR689LGR710LGR756LHH468LHH469LHH560LHH608LHH686LHH784LHP498LHP599LHP602LHP868
- Amount recalled
- 20,090 eaches (10,545 units)
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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