Home / Recalls / Cook Incorporated / Z-1830-2022

Z-1830-2022 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
2,748 US; 302 OUS

Product Description

Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077

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 G05183 UDI-DI: 00827002051836 Lot/Expiration Date 14795012 15-06-2027 14801636 20-06-2027 14804264 21-06-2027 14804265 21-06-2027 14806984 22-06-2027 14806985 22-06-2027 14815841 27-06-2027 14815842 27-06-2027 14815852 27-06-2027 14815853 27-06-2027 14815854 27-06-2027 14819080 29-06-2027 14819081 29-06-2027 14831205 07-07-2027 14831206 07-07-2027 14841236 14-07-2027 PMG-18SP-100-COPE G05822 UDI-DI: 00827002058224 Lots/Expiration Dates 14797819 16-06-2027 PMG-18SP-125-COPE G10077 UDI-DI: 00827002100770 Lots/Expiration Dates 14809295 23-06-2027 14809296 23-06-2027

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)