FDA recall Z-0796-2025

Med Michigan Holding Llc · Class II · device

Product

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.

Reason for recall

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

Distribution

Product distributed to a distributor located in IL.

Key facts

Status
Ongoing
Initiation date
2024-11-19
Report date
2025-01-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Walker, MI, United States

Primary source

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