Home / Recalls / Cook Incorporated / Z-1841-2022

Z-1841-2022 Class II Ongoing

Recalled by Cook Incorporated — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
October 5, 2022
Initiation Date
August 16, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
363 US; 244 OUS

Product Description

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

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.

Distribution Pattern

Domestic distribution nationwide. Foreign distribution worldwide.

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

Other recalls by Cook Incorporated

  • Z-1935-2026 Class I — Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G473 (April 2, 2026)
  • Z-1934-2026 Class I — Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Cath (April 2, 2026)
  • Z-1936-2026 Class I — Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G312 (April 2, 2026)
  • Z-1791-2026 Class II — COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IM (March 5, 2026)
  • Z-1780-2026 Class II — COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Re (March 5, 2026)
  • Z-1790-2026 Class II — COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Or (March 5, 2026)
  • Z-1781-2026 Class II — COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Refer (March 5, 2026)
  • Z-1779-2026 Class II — COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Refe (March 5, 2026)
  • Z-1776-2026 Class II — COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-19 (March 5, 2026)
  • Z-1775-2026 Class II — COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6 (March 5, 2026)