Class 2 Device Recall Rigid Intracardiac Sucker

• Date Initiated by Firm: November 19, 2024
• Date Posted: December 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0796-2025
• Recall Event ID: 95889
• 510(K)Number: K971022
• Product Classification: Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
• 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.
• Code Information: UDI-DI 00817278010514 Lot 08294-080724
• FEI Number: 3017540705
• Recalling Firm/ Manufacturer: Med Michigan Holding Llc; 2680 Walker Ave Nw Ste C; Walker MI 49544-1385
• Manufacturer Reason for Recall: Incomplete or partial pouch seals, which may result in a breach in the sterility.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 109 boxes (2,180 eaches)
• Distribution: Product distributed to a distributor located in IL.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GCX