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MERIGLUETM – Topical Skin Adhesive

MERIL ENDO SURGERY PRIVATE LIMITED · Model BCA-0.5 · UDI-DI 08904255228665

MPN Prescription

510(k) clearances

3,646

Adverse events (7 deaths)

Recalls

Facilities

Description

The MeriGlu™ is a sterile, liquid topical skin tissue adhesive containing a monomer (N-Butyl Cyanoacrylate(97 %), Plasticizer – Acetyl Tri-Butyl Citrate (2.8 %) and the Colorant D & C Violet No. 2 (0.2 %). It is provided in a sealed aluminium tube with a loosely attached single use nozzle. Both aluminum tube and nozzles are individually packed in PET tray with Tyvek lid. The nozzles are composed of a selfpuncturing closure and a soft tip which provides uniform spreading of adhesive on application site. As applied to skin tissues, the liquid adhesive polymerizes within minutes.

Recalls

Date	Firm	Reason
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2021-01-04	Ethicon, Inc.	Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.