Recall Z-0796-2025— Med Michigan Holding Llc

Name: FDA recall Z-0796-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-19

Class II · Ongoing

Class II FDA medical device recall by Med Michigan Holding Llc, initiated 2024-11-19. It names one FDA 510(k) clearance: K971022. 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: Incomplete or partial pouch seals, which may result in a breach in the sterility..

Recalling firm: Med Michigan Holding Llc
Classification: Class II
Status: Ongoing
Initiated: 2024-11-19
Firm location: Walker, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K971022 — CHASE SUCKERChase Medical, Inc.·cleared 1997-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.