Cook Incorporated: Medical Device Recall in 2022 - (Recall #: Z-1836-2022)

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:

Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561

Product Classification:

Class II

Date Initiated: August 16, 2022

Date Posted: October 5, 2022

Recall Number: Z-1836-2022

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: 42 US

Code Information:

TSFNA-35-145 G00701 UDI-DI: 00827002007017 Lots/Expiration Date: 14798674 16-06-2027 TSCFNA-35-145-3 G00561 UDI-DI: 00827002005617 Lots/Expiration Date: 14835600 11-07-2027

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated