Recall archive / FDA device enforcement
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 — FDA record Z-1839-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Cook Incorporated
- Quantity
- 202 US; 11 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1839-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 5, 2022
- Recall initiation date
- Aug 16, 2022
- Center classification date
- Sep 28, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.