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Stradis Medical, LLC dba Stradis Healthcare Recall 91124

Page Last Updated: November 21, 2024

Description: STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,

Stradis Medical, LLC dba Stradis Healthcare Recall 91124 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0546-2023
Event ID91124
Event DescriptionSTRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
Product TypeDevices
DistributionUS nationwide distribution, and Canada.
Quantity30 units
Recall ReasonMedical 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.
Device Classification20221221
Device Code InfoUDI/DI (case) M7526821993R11, UDI/DI (kit)M7526821993R10, Serial/Lot Numbers: 22235491208
Center Classification Date20221214
Recall Initiation Date20221102
Recalling FirmStradis Medical, LLC dba Stradis Healthcare
Initial Notification E-Mail
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