Medical device recalls Moderate risk

Medline Industries Inc recalls Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgerie…

Recall date
November 13, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0779-2021
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

Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

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