Home / Recalls / Cook Incorporated / Z-0499-2025

Z-0499-2025 Class II Ongoing

Recalled by Cook Incorporated — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
November 27, 2024
Initiation Date
October 14, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 units

Product Description

Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

Reason for Recall

Devices from the affected device lots have labels that state the incorrect expiration dates.

Distribution Pattern

International Distribution to: Korea only

Code Information

UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020

Other recalls by Cook Incorporated

  • Z-0994-2026 Class II — Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-1 (November 26, 2025)
  • Z-0993-2026 Class II — Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18 (November 26, 2025)
  • Z-0995-2026 Class II — R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; (November 26, 2025)
  • Z-1902-2025 Class I — Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic a (May 15, 2025)
  • Z-1786-2025 Class II — Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10. (April 17, 2025)
  • Z-1787-2025 Class II — Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14. (April 17, 2025)
  • Z-1762-2025 Class II — Tornado Embolization Microcoil, intended for embolization of selective vessel su (April 17, 2025)
  • Z-0346-2025 Class II — Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part (October 8, 2024)
  • Z-0347-2025 Class II — Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers (October 8, 2024)
  • Z-0045-2025 Class II — Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order (September 16, 2024)