Z-1147-2018 Class II Terminated
FDA device recall Z-1147-2018 was initiated by Ethicon, Inc. on November 27, 2017 and is designated Class II. 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. The recall status is terminated (terminated April 30, 2019). Affected quantity: 20,090 eaches (10,545 units).
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- November 27, 2017
- Termination Date
- April 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,090 eaches (10,545 units)
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.
Distribution Pattern
US Nationwide Distribution
Code Information
LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868