Home › SUN SCIENTIFIC, INC. › AeroWrap™ Full Leg

AeroWrap™ Full Leg

SUN SCIENTIFIC, INC. · Model FL-FR-MLR-L-XLF-S · UDI-DI 00850070012010

MHW Prescription

510(k) clearances

Adverse events (5 deaths)

Recalls

235

Facilities

Description

The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the knee a Thigh sleeve from the knee to the crotch, a compression knee wrap, and a foot compression wrap. A hand pump is included to provide static compression for compression therapy. The AeroWrap™ Full Leg gradient compression system sleeves are non-sterile single patient use medical devices. An inflation source can be attached to the inflation valve on the sleeve. There is a hand pump provided as an inflation source to provide static compression. The systems are 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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.