Device product

STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular

Z-0500-2023

November 02, 2022

Class II

Product summary

Firm: Stradis Medical, LLC dba Stradis Healthcare
Event: Event 91124
Status: Ongoing
Classification: Class II
Quantity: 180 units
Official record key: device-enforcement:Z-0500-2023

Official wording

Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Code information: UDI/DI (case) M7525250381, UDI/DI (kit)M7525250380, Serial/Lot Numbers: 22251491752,

Distribution pattern: US nationwide distribution, and Canada.

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0

bag being incompletely sealed, which may result in a breach in the sterility