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SOLIDEA

CALZIFICIO PINELLI SRL · Model 069232 · UDI-DI 08300496069232

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

Description

SKIN, SIZE XL, CHAMPAGNE, MICRO-MASSAGING BRA WITH A THREE-DIMENSIONAL CONSTRUCTION FOR A COMFORTABLE BREAST SUPPORT

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.