Binder, Medical, Therapeutic
General Hospital · 21 CFR 880.5160
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
19 recall events for this product code
- Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap Large Short 28cm Length with Anklet Catalog 23025017
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1684-2010 · View FDA record ↗ - Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap Medium Short 28cm Length with Anklet Catalog 23024017
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1685-2010 · View FDA record ↗ - Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap XL Short 28cm Length with Anklet Catalog 23026017
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1686-2010 · View FDA record ↗ - Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Anklet Catalog 23026117
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1687-2010 · View FDA record ↗ - Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap Large Full Calf Short 28cm Length with Anklet Catalog 23025117
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1688-2010 · View FDA record ↗ - Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap XXLShort 28cm Length with Anklet Catalog 23027017
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1689-2010 · View FDA record ↗ - Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap XL Long 33cm Length with Anklet Catalog 23036017
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1690-2010 · View FDA record ↗ - Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Anklet Catalog 23036117
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1691-2010 · View FDA record ↗ - Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap Medium Short 28cm Length with Separate Small AFW Catalog 23124017
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1692-2010 · View FDA record ↗ - Circaid Medical Products IncTerminatedMay 27, 2010
Juxta-Lite compression wrap Large Short 28cm Length with Separate Small AFW Catalog 23125017
Some 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 applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
Z-1693-2010 · View FDA record ↗
Registered firms
68 firms currently registered for this product code
Sigvaris Inc. - Holland Facility
Holland, MI, US
Bsn Medical S.a. De C.v.
Reynosa Tamaulipas, MX
Medtech Acuna S.a. De C.v.
Acuna Coahuila, MX
Pure Medical Inc.
Wauwatosa, WI, US
Vive Health Llc
Naples, FL, US
S2s Innovations, Inc.
Toronto Ontario, CA
Marina Medical Instruments, Inc.
Davie, FL, US
Vitaform, Inc.
Dana Point, CA, US
Bsn Medical Inc.
Hickory, NC, US
American Breast Care Lp
Marietta, GA, US
L&r Usa Inc.
Milwaukee, WI, US
Pattersonpouch
Roanoke, VA, US
Qualiteam S.r.l.
Burolo Piedmont, IT
Vivell Sas
Medellin Antioquia, CO
The Hygenic Company, Llc
Akron, OH, US
Manifattura Ci-zeta Srl
Passirano Brescia, IT
Icat S.a. De C.v.
San Salvador, SV
Bsn-jobst Gmbh
EMMERICH North Rhine-Westphalia, DE
Ta Lai Sporting Goods Enterprises Co. Ltd.
NEW TAIPEI CITY, TW
Essity Distribution B.v.
GE Oostrum Fryslan, NL
The Marena Group, Llc.
LAWRENCEVILLE, GA, US
My True Image Mfg.
RICHMOND, CA, US
Medical Z, S.a.
SAINT AVERTIN Indre-et-Loire, FR
Alta Medical Llc
Milwaukee, WI, US
Thuasne, Llc
Hamlet, NC, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.