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MEDI

MEDI MANUFACTURING, INC. · Model RLYUN001P · UDI-DI 00837654862001

MDR
0
510(k) clearances
2
Adverse events (1 deaths)
19
Recalls
68
Facilities

Description

COMFORT ARM LINER PACKAGED

Recalls

DateFirmReason
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a
2010-04-20Circaid Medical Products IncSome systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a

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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.