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AeroWrap™

SUN SCIENTIFIC, INC. · Model Large · UDI-DI 00856525007280

MHW Prescription

510(k) clearances

Adverse events (5 deaths)

Recalls

235

Facilities

Description

The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg. An inflation source is attached to the inflation valve on the sleeve. There is a inflation source provided: a hand pump to provide static compression. The system is intended for hospital and outpatient use.

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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Data 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.