COVIDIEN LLC recalls Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736

Recall date

February 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1041-2019

FDA classification

Class II

Brand / firm

COVIDIEN LLC

Sold / distributed

The products were distributed to the following US states: CA, NJ, and WA.

Why it was recalled

The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736