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AeroWrap Thigh Medium Large Left
SUN SCIENTIFIC, INC. · Model TW6250-01 · UDI-DI 00856525007099
MHW
Prescription
2
510(k) clearances
70
Adverse events (5 deaths)
6
Recalls
238
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 |
|---|---|---|
| 2026-09-02 | Safeguard US Operating LLC | Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of s |
| 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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