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OSSEOUS- Adhesion Remover Pad

EON MEDITECH PRIVATE LIMITED · Model EA91063 · UDI-DI 08904428745012

KOX Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

101

Facilities

Description

The Adhesive removal pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and absorb secretions. It enlarges during use. If due to this it slips off the tube or tears easily it is worn out and needs to be replaced. Helps to remove an adhesive. Alcohol-free and removes adhesive and adhesive residue easily.

Recalls

Date	Firm	Reason
2011-04-04	Smith & Nephew Inc.	Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SK
2011-04-04	Smith & Nephew Inc.	Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SK
2010-07-07	Ferndale Laboratories, Inc.	There is a defect on the neck surface of the bottles, causing bottles to leak. Bottle defect may potentially cause contamination of solvent stored in bottles.

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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.