FDA-Device2025-01-08Class II

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.

Med Michigan Holding Llc
Hazard

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

Sold states
Product distributed to a distributor located in IL.
Affected count
109 boxes (2,180 eaches)
Manufactured in
2680 Walker Ave Nw Ste C, Walker, MI, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0796-2025

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