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H&H Mini 2X Bandage/Gauze Combo Pack

H&H MEDICAL CORPORATION · Model 1 · UDI-DI 00857048006583

MHW

510(k) clearances

Adverse events (5 deaths)

Recalls

235

Facilities

Description

The bundle combines gauze for wound packing and wrapping with our smallest compression bandage. It fits in your pack easily and is the perfect combination for on-the-go trauma response. Mini 2x - Gauze + Compression from H&H Med Corp includes: (1) Mini Compression Bandage (1) MiniTAC Wound Gauze. Single-Use. Sterile.

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.