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Cordis Corporation Recall 88112

Description: Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Cordis Corporation Recall 88112 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2079-2021
Event ID88112
Event DescriptionAvanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
Quantity680 units
Recall ReasonThe product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Device Classification20210721
Device Code InfoCatalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023
Center Classification Date20210715
Recall Initiation Date20210609
Recalling FirmCordis Corporation
Initial Notification Letter
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