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
Enforcement
- Recall Number
- Z-1837-2022
- Event ID
- 90793
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 5, 2022
- Initiation Date
- August 16, 2022
- Classification Date
- September 28, 2022
- Address
- 750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States
Description
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
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.
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
Domestic distribution nationwide. Foreign distribution worldwide.
56 US; 1033 OUS