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HidraWear
HIDRAMED SOLUTIONS LIMITED · Model GAX001-05 · UDI-DI 05391535510092
MDR
Prescription
0
510(k) clearances
2
Adverse events (1 deaths)
19
Recalls
68
Facilities
Description
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Extra Large
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.