Cook Incorporated: Medical Device Recall in 2022 - (Recall #: Z-1835-2022)

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:

Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925

Product Classification:

Class II

Date Initiated: August 16, 2022

Date Posted: October 5, 2022

Recall Number: Z-1835-2022

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: 25 US

Code Information:

THDOC-35-60-0-3 G11949 UDI-DI: 00827002119499 Lots/Expiration Dates: 14797780 16-06-2027 C-HDOC-18-40-0-2 G09201 UDI-DI: 00827002092013 Lots/Expiration Dates: NS14807603 22-06-2027 C-THDOC-18-40-0-2-HTS G26925 UDI-DI: 00827002269255 Lots/Expiration Dates: NS14818388 29-06-2027

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated