Cook Incorporated: Medical Device Recall in 2022 - (Recall #: Z-1846-2022)

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:

Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678

Product Classification:

Class II

Date Initiated: August 16, 2022

Date Posted: October 5, 2022

Recall Number: Z-1846-2022

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: No distribution (Distribution Center only)

Code Information:

TCMTNA-35-145-3 G01678 UDI-DI: 00827002016781 Lots/Expiration Dates: 14808819 22-06-2027 NS14821223 30-06-2027 NS14851713 21-07-2027

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated