Cook Incorporated: Medical Device Recall in 2022 - (Recall #: Z-1838-2022)

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 (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607

Product Classification:

Class II

Date Initiated: August 16, 2022

Date Posted: October 5, 2022

Recall Number: Z-1838-2022

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: 277 US; 138 OUS

Code Information:

RFSPC-35-145 G09607 UDI-DI: 00827002096073 Lot/Expiration Date: 14831437 07-07-2025 14831438 07-07-2025 14835040 11-07-2025 14840287 13-07-2025 14840288 13-07-2025 14840309 13-07-2025

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated