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Cofoe

Cofoe Medical Technology Co.,Ltd · Model KF-WAX-01 · UDI-DI 06950715501481

DWL

510(k) clearances

Adverse events (3 deaths)

Recalls

105

Facilities

Description

The Compression Socks are intended for use by individuals who require increased blood flow in the legs, such as those with venous insufficiency, varicose veins, or who are at risk of developing deep vein thrombosis (DVT). They are also suitable for individuals who spend long hours standing or sitting, such as nurses, office workers, or travelers.

Recalls

Date	Firm	Reason
2014-03-19	Zimmer, Inc.	During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
2014-03-19	Zimmer, Inc.	During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
2014-03-19	Zimmer, Inc.	During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
2014-03-19	Zimmer, Inc.	During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

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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.