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AeroWrap Thigh Small Right
SUN SCIENTIFIC, INC. · Model TW6150-03 · UDI-DI 00856525007211
MHW
Prescription
2
510(k) clearances
70
Adverse events (5 deaths)
5
Recalls
237
Facilities
Description
The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein on the thigh after closure to occlude the vein after surgery. The wrap consists of a inflatable portion that covers the inner thigh and additional material along with areas for securing the wrap to the thigh. The wrap also has loops for a belt to maintain the proper location. The placement of the wrap and sv bolster will help to aid in the closure of Various veins with Sclerotherapy including EVLT, RFMD, for compression of the great saphenous vein.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-02-24 | Amd Ritmed | Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus. |
| 2006-08-16 | International Medsurg Connection, Inc. | The bandages labeled as sterile had not been sterilized prior to distribution. |
| 2006-08-16 | International Medsurg Connection, Inc. | The bandages labeled as sterile had not been sterilized prior to distribution. |
| 2006-08-16 | International Medsurg Connection, Inc. | The bandages labeled as sterile had not been sterilized prior to distribution. |
| 2006-08-16 | International Medsurg Connection, Inc. | The bandages labeled as sterile had not been sterilized prior to distribution. |
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