DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended f...

FDA Device Recall #Z-1147-2018 — Class II — November 27, 2017

Recall Summary

Recall Number Z-1147-2018
Classification Class II — Moderate risk
Date Initiated November 27, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ethicon, Inc.
Location Somerville, NJ
Product Type Devices
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

Lot / Code Information

LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868

Other Recalls from Ethicon, Inc.

Recall # Classification Product Date
Z-0487-2025 Class II MONOCRYL" (poliglecaprone 25) Suture REF Y936H ... Oct 8, 2024
Z-0319-2025 Class II Coated VICRYL Polyglactin 910 Suture VIO 36IN(9... Sep 25, 2024
Z-2148-2024 Class II MONOCRYL (poliglecaprone 25) Suture - Intended ... May 10, 2024
Z-2144-2024 Class II VICRYL (polyglactin 910) Suture - Indicated for... May 10, 2024
Z-2147-2024 Class II PDS Plus Antibacterial (polydioxanone) Suture -... May 10, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.