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.
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-0796-2025Don't want to check this manually?
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