PlainRecalls
FDA Devices Moderate Class II Terminated

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 temporar

Reported: March 28, 2018 Initiated: November 27, 2017 #Z-1147-2018

Product Description

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.

Details

Recalling Firm
Ethicon, Inc.
Units Affected
20,090 eaches (10,545 units)
Distribution
US Nationwide Distribution
Location
Somerville, NJ

Frequently Asked Questions

What product 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. Recalled by Ethicon, Inc.. Units affected: 20,090 eaches (10,545 units).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 28, 2018. Severity: Moderate. Recall number: Z-1147-2018.

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