Z-0796-2025 Class II Ongoing
FDA device recall Z-0796-2025 was initiated by Med Michigan Holding Llc on November 19, 2024 and is designated Class II. Reason for recall: Incomplete or partial pouch seals, which may result in a breach in the sterility. The recall status is ongoing. Affected quantity: 109 boxes (2,180 eaches).
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2025
- Initiation Date
- November 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109 boxes (2,180 eaches)
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.
Reason for Recall
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Distribution Pattern
Product distributed to a distributor located in IL.
Code Information
UDI-DI 00817278010514 Lot 08294-080724