Home / Recalls / Cook Incorporated / Z-1240-2022

Z-1240-2022 Class II Ongoing

Recalled by Cook Incorporated — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
June 15, 2022
Initiation Date
May 5, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
106,033

Product Description

Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

Reason for Recall

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Distribution Pattern

Domestic distribution nationwide. Foreign distribution worldwide.

Code Information

Lots: 14212811 14215685 14212247 14212812 14212814 14215682 14361413 14361416 14285326 14285328 14285330 14297289 14361412 14445407 14444454 14477949 14477950 UDI: (01)00827002474994(17)261013(10)14212811 (01)00827002474994(17)261008(10)14215685 (01)00827002474987(17)261011(10)14212247 (01)00827002474987(17)261008(10)14212812 (01)00827002474994(17)261008(10)14212814 (01)00827002474994(17)261008(10)14215682 (01)00827002474994(17)261219(10)14361413 (01)00827002474994(17)261220(10)14361416 (01)00827002474987(17)261110(10)14285326 (01)00827002474987(17)261110(10)14285328 (01)00827002474994(17)261110(10)14285330 (01)00827002474994(17)261123(10)14297289 (01)00827002474987(17)261220(10)14361412 (01)00827002474987(17)270207(10)14445407 (01)00827002474994(17)270207(10)14444454 (01)00827002474987(17)270217(10)14477949 (01)00827002474994(17)270216(10)14477950

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)