Home › SIGVARIS INC › Cflex Contain Full Leg LG XL XL Tall Left Beige
Cflex Contain Full Leg LG XL XL Tall Left Beige
SIGVARIS INC · Model 341344-THT-L · UDI-DI 00745129317331
0
510(k) clearances
2
Adverse events (1 deaths)
19
Recalls
68
Facilities
Description
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
| 2010-04-20 | Circaid Medical Products Inc | 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 a |
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Get your free API keyRead the docsData 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.