SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indica...
FDA Recall #Z-0796-2025 — Class II — November 19, 2024
Product Description
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.
Recalling Firm
Med Michigan Holding Llc — Walker, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
109 boxes (2,180 eaches)
Distribution
Product distributed to a distributor located in IL.
Code Information
UDI-DI 00817278010514 Lot 08294-080724
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated