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Sion Biotext Medical Ltd.

SION BIOTEXT MEDICAL LTD · Model 1 · UDI-DI 07290101428350

NAE

510(k) clearances

105

Adverse events

Recalls

304

Facilities

Description

The Amorphous Hydrogel product family is intended to maintain a moist environment by donating moisture to dry or minimally exudating wounds. Viscous and non-oily formulation remains in place in the wound bed. The products are non-sterile, intended for multi-use with continuous use of up to 30 days. Not made with natural rubber latex | Non-cytotoxic | Non-irritating

Recalls

Date	Firm	Reason
2020-02-11	Nelson Innovaions, Llc	Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
2018-08-22	Safe N Simple, LLC	The sterilization process used was unqualified.
2018-08-22	Safe N Simple, LLC	The sterilization process used was unqualified.
2016-09-01	CellEra LLC	Adhesive border was not sticky enough.
2015-09-30	O-Two Medical Technologies, Inc.	For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches o
2006-11-09	Embeem Inc.	Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material

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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.