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OSSEOUS- Skin Preparation Pad

EON MEDITECH PRIVATE LIMITED · Model EA91062 · UDI-DI 08904428721405

NEC Prescription

510(k) clearances

Adverse events (6 deaths)

Recalls

142

Facilities

Description

The Skin preparation 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. Provides a protective layer between skin and adhesive Alcohol-free and used after cleaning the skin, before applying an adhesive.

Recalls

Date	Firm	Reason
2018-08-30	MEDLINE INDUSTRIES INC	Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
2012-06-18	Safe N Simple, LLC	The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of in
2011-05-31	BioDerm, Inc.	On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male
2011-05-31	BioDerm, Inc.	On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male
2011-05-31	BioDerm, Inc.	On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Cl
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

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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.