Med Michigan Holding Llc: Device Recall
Recall #Z-0796-2025 · 11/19/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0796-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Med Michigan Holding Llc
- Status
- Ongoing
- Date Initiated
- 11/19/2024
- Location
- Walker, MI, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109 boxes (2,180 eaches)
Reason for Recall
Incomplete or partial pouch seals, which may result in a breach in the sterility.
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.
Distribution Pattern
Product distributed to a distributor located in IL.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.