Device 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
Z-1147-2018
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 79355
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,090 eaches (10,545 units)
- Official record key
device-enforcement:Z-1147-2018
Official wording
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.
Code information: LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.