Z-0796-2025Class II

SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for...

Name: Z-0796-2025 SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for...
Creator: Med Michigan Holding Llc
Published: 2024-11-19
License: https://open.fda.gov/license/

Med Michigan Holdings LLC / initiated 2024-11-19 / Open, Classified / root cause: manufacturing process

FDA source

Med Michigan Holding Llc began a recall of 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... on 2024-11-19. FDA classified it as Class II and gives the reason as "Incomplete or partial pouch seals, which may result in a breach in the sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0796-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-19
Posted: 2024-12-31
Recalling firm: Med Michigan Holdings LLC
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.
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Reason for recall: Incomplete or partial pouch seals, which may result in a breach in the sterility.
Root cause tag: manufacturing process
FDA root 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 [email protected].
Quantity in commerce: 109 boxes (2,180 eaches)
Distribution: Product distributed to a distributor located in IL.
Product codes and lots: UDI-DI 00817278010514 Lot 08294-080724

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0796-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0796-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-31

Product code GCX

K971022Class IIChase SuckerChase Medical, Inc. / cleared 1997-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)