FDA Medical devices recall ·
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip recall
- Recall number
- Z-0796-2025
- Date
- (initiated November 19, 2024)
- Company / brand
- Med Michigan Holding Llc
2680 Walker Ave Nw Ste C, Walker, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 109 boxes (2,180 eaches)
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Incomplete or partial pouch seals, which may result in a breach in the sterility.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 00817278010514 Lot 08294-080724
Distribution
Product distributed to a distributor located in IL.
States: Illinois
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0796-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.