FDA Device recall Z-0961-2020
Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260 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-0961-2020 |
| 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
Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
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 | 7875295 8481133 NS8481135 |
|---|
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-0961-2020%22
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