Cook Incorporated: Medical Device Recall in 2022 - (Recall #: Z-1841-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534

Product Classification:

Class II

Date Initiated: August 16, 2022

Date Posted: October 5, 2022

Recall Number: Z-1841-2022

Event ID: 90793

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 363 US; 244 OUS

Code Information:

RPC-35-145 G06979 UDI-DI: 00827002069794 Lots/Expiration Date: 14774168 07-06-2025 14810021 23-06-2025 14813491 27-06-2025 14816228 28-06-2025 14835046 11-07-2025 14835049 11-07-2025 14845506 18-07-2025 NS14813489 27-06-2025 NS14813489X 27-06-2025 RPC-35-80 G09534 UDI-DI: 00827002095342 Lots/Expiration Date: 14823405 01-07-2025 14823407 01-07-2025 14823408 01-07-2025

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated