Device 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.
Z-0796-2025
Product summary
- Event
- Event 95889
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 109 boxes (2,180 eaches)
- Official record key
device-enforcement:Z-0796-2025
Official wording
Reason: Incomplete or partial pouch seals, which may result in a breach in the sterility.
Code information: UDI-DI 00817278010514 Lot 08294-080724
Distribution pattern: Product distributed to a distributor located in IL.
Derived failure modes
-
Sterility assurance
seals, which may result in a breach in the sterility