FDA Device recall Z-1839-2022
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 by Cook, citing cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1839-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-16 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook |
| Distribution | US |
Product
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
Reason
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Identifiers
| code_info | RFPC-35-145 G07914 UDI-DI: 00827002079144 Lots/Expiration Date: 14828624 06-07-2025 14828638 06-07-2025 14837046 12-07-2025 NS14828650 06-07-2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1839-2022%22
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