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Terminated

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

FDA Recall Z-1147-2018 · Posted None

Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeOMO
Date Initiated2017-11-27
Date Terminated2019-04-30
Product Quantity20,090 eaches (10,545 units)

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.

Firm Action

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.

Root Cause

Component change control

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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