Recall archive / FDA device enforcement
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-0351... — FDA record Z-1837-2022
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 Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542
- 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
- 56 US; 1033 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1837-2022
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 | RPC-035145-0-5 G34131 UDI-DI: 00827002341319 Lot/Expiration Date: 14769270X 03-06-2025 14802181 20-06-2025 14816224 28-06-2025 14818488 29-06-2025 14818489 29-06-2025 14828627 06-07-2025 14828629 06-07-2025 RPC-035145 G18154 UDI-DI: 00827002181540 Lot/Expiration Date: 14770863 06-06-2025 14770864 06-06-2025 14813490 27-06-2025 14816227 28-06-2025 NS14770866 06-06-2025 NS14804982 21-06-2025 RPC-035145-5 G34132 UDI-DI: 00827002341326 Lot/Expiration Date: 14770872 06-06-2025 14810022 23-06-2025 14831440 07-07-2025 RPC-038145-0-5 G34129 UDI-DI: 00827002341296 Lot/Expiration Date: 14804972 21-06-2025 14809971 23-06-2025 RFSPC-038145-0 G17539 UDI-DI: 00827002175396 Lot/Expiration Date: 14809157 23-06-2025 14837048 12-07-2025 RFSPC-035145 G17540 UDI-DI: 00827002175402 Lot/Expiration Date: 14818484 29-06-2025 14818485 29-06-2025 14818490 29-06-2025 14840310 13-07-2025 RPC-038145-0 G18155 UDI-DI: 00827002181557 Lot/Expiration Date: 14819269 29-06-2025 14823406 01-07-2025 14832976 08-07-2025 NS14828649 06-07-2025 RPC-035145-0 G18153 UDI-DI: 00827002181533 Lot/Expiration Date: 14828625 06-07-2025 14828630 06-07-2025 14828635 06-07-2025 14828636 06-07-2025 14828637 06-07-2025 14828640 06-07-2025 14828641 06-07-2025 14841469 14-07-2025 NS14813479 27-06-2025 NS14818486 29-06-2025 RFSPC-035145-0 G17542 UDI-DI: 00827002175426 Lot/Expiration Date: 14844152 15-07-2025 |
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.