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TRAMEDIC® TRAUMA BANDAGE

TACTICAL MEDICAL SOLUTIONS, LLC · Model A · UDI-DI 00818630011705

MHW

510(k) clearances

Adverse events (5 deaths)

Recalls

235

Facilities

Description

The Tramedic® Trauma Bandage is a simple, effective pressure dressing designed to treat non-life threatening hemorrhaging. It utilizes an elastic wrap material that can be used to generate pressure and a sterile wound pad that can be placed directly over the injury to aid the control of bleeding. The bandage is flat folded and vacuum-sealed to create a low profile so it can be easily stored.

Recalls

Date	Firm	Reason
2016-02-24	Amd Ritmed	Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
2006-08-16	International Medsurg Connection, Inc.	The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16	International Medsurg Connection, Inc.	The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16	International Medsurg Connection, Inc.	The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16	International Medsurg Connection, Inc.	The bandages labeled as sterile had not been sterilized prior to distribution.

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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.