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Cordis Corporation Recall 88821

Description: SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Cordis Corporation Recall 88821 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0221-2022
Event ID88821
Event DescriptionSMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Product TypeDevices
DistributionUS Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
Quantity4 units
Recall ReasonThere is a potential for distal tip dislodgement or separation.
Device Classification20211124
Device Code InfoProduct Code: SF10100MB; Lot No. 271626
Center Classification Date20211112
Recall Initiation Date20211001
Recalling FirmCordis Corporation
Initial Notification Letter
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