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Foot Compression Wrap Large
SUN SCIENTIFIC, INC. · Model MW5360 · UDI-DI 00856525007976
MHW
Prescription
2
510(k) clearances
70
Adverse events (5 deaths)
5
Recalls
237
Facilities
Description
Aero-Wrap™ Foot Compression Wrap is designed to provide therapeutic compression therapy, in the inpatient and outpatient setting, in the treatment of edema and lymphedema of the foot or as part of a wound treatment protocol.
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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