Med Michigan Holding LLC recalls SUC-4300S

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

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.

On November 19, the firm notified customers via URGENT PRODUCT RECALL NOTICE letters. Customers were provided with an RGA number and instructions to return affected product to the firm as soon as possible. If you have any questions about this recall communication, please contact Lindsey Allende lallende@medalliancegroup.com.

• FDA enforcement recordOfficial FDA database entry for Z-0796-2025
• FDA 510(k) clearance · K971022The device's official FDA premarket clearance record
• FDA device classification · GCXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.6740The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Med Michigan Holding LlcSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.