Recall Z-1147-2018— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2017-11-27, terminated 2019-04-30. It names one FDA 510(k) clearance: K133864. 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: Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-27
- Terminated
- 2019-04-30
- Firm location
- Somerville, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.