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Open, Classified

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.

FDA Recall Z-0796-2025 · Posted 2024-12-31

Recalling FirmMed Michigan Holding Llc
Recall StatusOpen, Classified
Product CodeGCX
Date Initiated2024-11-19
Product Quantity109 boxes (2,180 eaches)

Reason for Recall

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

Firm 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 [email protected].

Root Cause

Process control

Distribution Pattern

Product distributed to a distributor located in IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971022CHASE SUCKERChase Medical, Inc. · 1997-04-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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