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AMD-RITMED

AMD Medicom Inc · Model A605-IND · UDI-DI 10686864055461

MHW
2
510(k) clearances
70
Adverse events (5 deaths)
5
Recalls
235
Facilities

Description

AMD-RITMED CONFORMING BANDAGES 6 Inch X 4.1 Yard

Recalls

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