FDA Device recall Z-0324-2018
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tr…
- FDA Device
- Class II
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class II recall of Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tr… by Cordis, citing potential for cracked luer hubs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0324-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-15 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cordis |
| Distribution | US |
Product
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
Reason
Potential for cracked luer hubs
Identifiers
| code_info | GTIN Catalog Lot Numbers ----------------------------…GTIN Catalog Lot Numbers ------------------------------------------------------------------------------------------------ 20705032065600 SF05100MB 41316 and 41352, 20705032065648 SF06100MB 41318 and 41353, 20705032065723 SF06120MB 40997 and 41354, 20705032066034 SF06150MB 41198 and 41355, 20705032065747 SF07080MB 41319, 20705032065655 SF07100MB 40999 and 41199, 20705032065617 SF07150MB 41200 and 41356, 20705032065662 SF08100MB 41320, 20705032066348 SF08120MB 41056, 20705032066171 SF09030MB 41055, 20705032066164 SF09030SB 41203, 2070503206626 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0324-2018%22
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