Medline Industries Inc recalls Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries includ…

Recall date

November 13, 2020

Source

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

Recall number

Z-0783-2021

FDA classification

Class II

Brand / firm

Medline Industries Inc

Sold / distributed

Foreign distribution only - Canada.

Why it was recalled

The cylindrical sponge component is not x-ray detectable.

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

What was recalled

Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.