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Recall Observatory FDA recall evidence

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

November 19, 2024

Class II

Product summary

Firm
Med Michigan Holding Llc
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

    reason.sterility_assurance · v1.0.0

    seals, which may result in a breach in the sterility