Home / Recalls / Cook Incorporated / Z-1829-2022

Z-1829-2022 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
1,501 US; 380 OUS

Product Description

Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427

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

PMG-18SP-60-COPE-NT-ST G09395 UDI-DI: 00827002093959 Lot/Expiration Date 14809498 23-06-2027 14809499 23-06-2027 14811841 24-06-2027 PMG-18SP-100-COPE-NT G08687 UDI-DI: 00827002086876 Lot/Expiration Date 14811839 24-06-2027 14839563 13-07-2027 PMG-18SP-60-COPE-NT G08427 UDI-DI: 00827002084278 Lot/Expiration Date 14816750 28-06-2027 14816753 28-06-2027 14816754 28-06-2027 14816755 28-06-2027 14816757 28-06-2027 14821755 30-06-2027 14821756 30-06-2027 14821758 30-06-2027 14831332 07-07-2027 14831333 07-07-2027 14831335 07-07-2027 14831336 07-07-2027 NS14813725 27-06-2027 NS14816751 28-06-2027 NS14821760 30-06-2027 NS14828069 05-07-2027 14809498 23-06-2027 14809499 23-06-2027 14811841 24-06-2027

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)