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STERILMED, INC. · Model STJ11161M · UDI-DI 10888551034814
NMF
Prescription
1
510(k) clearances
30
Adverse events
2
Recalls
0
Facilities
Description
FEMORAL COMPRESSION SYSTEM MODIFIED -- PUMP AND GAUGE NOT INCLUDED --
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-06-23 | Ascent Healthcare Solutions, Inc. | The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated. |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e |
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