Medical device recalls Moderate risk

Med Michigan Holding Llc recalls SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use o…

Recall date
November 19, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0796-2025
FDA classification
Class II
Brand / firm
Med Michigan Holding Llc
Sold / distributed
Product distributed to a distributor located in IL.

Why it was recalled

Incomplete or partial pouch seals, which may result in a breach in the sterility.

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

What was recalled

SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.

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