SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use on
Summary
The FDA issued a Class II for SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33c by Med Michigan Holding Llc. Reason: Incomplete or partial pouch seals, which may result in a breach in the sterility..
Details
Source
Device Recall
External ID
Z-0796-2025
Action Date
2025-01-08
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI-DI 00817278010514 Lot 08294-080724
Quantity Affected: 109 boxes (2,180 eaches)
Reason for Recall
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Distribution
Product distributed to a distributor located in IL.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-19
Company
Walker, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Med Michigan Holding Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Med Michigan Holding Llc have FDA actions?
This is the only FDA action we have on record for Med Michigan Holding Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0796-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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