Cook Incorporated: Medical Device Recall in 2022 - (Recall #: Z-1831-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145

Product Classification:

Class II

Date Initiated: August 16, 2022

Date Posted: October 5, 2022

Recall Number: Z-1831-2022

Event ID: 90793

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.

Status: Ongoing

Product Quantity: 150 US, 97 OUS

Code Information:

TDOC-35-145-0-3 G00362 UDI-DI: 00827002003620 Lots/Expiration Date: 14793053 14-06-2027 14797769 16-06-2027 14802346 20-06-2027 14802348 20-06-2027 14812034 24-06-2027 C-TDOC-18-50-0-2 G05146 UDI-DI: 00827002051461 Lots/Expiration Date: 14795065 15-06-2027 TDOC-35-50-0-3 G00364 UDI-DI: 00827002003644 Lots/Expiration Date: 14802347 20-06-2027 C-DOC-21-40-0-2 G02431 UDI-DI: 00827002024311 Lots/Expiration Date: NS14795068 15-06-2027 C-TDOC-21-50-0-2 G05195 UDI-DI:00827002051959 Lots/Expiration Date: NS14802356 20-06-2027 C-TDOC-25-50-0-2 G05145 UDI-DI: 00827002051454 Lots/Expiration Date: NS14818384 29-06-2027 NS14818387 29-06-2027

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated