FDA Device recall Z-0973-2020
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367 by Cook, citing the wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0973-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-04 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | US |
Product
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
Reason
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Identifiers
| code_info | NS7953136 NS8169661 NS8180857 NS8169662 NS8180858 NS8180859 NS8180860 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0973-2020%22
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