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Aero-Wrap™ Bilateral Kit, Small

SUN SCIENTIFIC, INC. · Model AW6180-03 · UDI-DI 00856525007495

MHW Prescription

510(k) clearances

Adverse events (5 deaths)

Recalls

235

Facilities

Description

The AeroWrap ™ Bilateral Kit System is comprised of two gradient compression sleeves, and a hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ kit system gradient compression sleeves are non-sterile single patient use medical device. The AeroWrap™ Bilateral Kit Gradient Compression Sleeves contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s legs from the ankle to the knee. 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.