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
This recall has been terminated (originally issued November 27, 2017).
- Company
- Ethicon, Inc. Us
- Recall Initiated
- November 27, 2017
- Terminated
- April 30, 2019
- Recall Number
- Z-1147-2018
- Quantity
- 20,090 eaches (10,545 units)
- Firm Location
- Somerville, NJ
- Official Source
- View on FDA website ↗
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
US Nationwide Distribution
Lot / Code Info
LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868
Root Cause
Component change control
Action Taken
Ethicon sent an URGENT MEDICAL DEVICE RECALL REMOVAL letter dated November 2017 to customers titled: "DERMABONDTM PRINEOTM SKIN CLOSURE SYSTEM (22 CM)". The letter identified the affected product, problem and action to be taken. The letter instructed customers to do not use or distribute any product which is subject to recall. Customers are asked to examine inventory, quarantine products that are subject to recall and contact the firm for return of product. Also, post the recall letter in a visible location at facility. If you have additional questions regarding this recall (removal) or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.