Surge Cardiovascular recallZ-0796-2025 · Med Michigan Holding Llc · initiated Nov 19, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Med Michigan Holding Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incomplete or partial pouch seals, which may result in a breach in the sterility.
FDA root cause category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-0796-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 19, 2024
- Posted by the FDA
- Dec 31, 2024
- Recalling firm
- Med Michigan Holding Llc
- Quantity
- 109 boxes (2,180 eaches)
- Product code
- GCX
- FDA submissions
- K971022
- Distribution
- Product distributed to a distributor located in IL.
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.
Code information (models, lots, serial numbers)
UDI-DI 00817278010514 Lot 08294-080724
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Surge Cardiovascular SUC-4300SMed Michigan Holdings, LLC · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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