Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-0399-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.

Product Classification:

Class I

Date Initiated: October 22, 2020

Date Posted: November 11, 2020

Recall Number: Z-0399-2021

Event ID: 86642

Reason for Recall:

Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.

Status: Terminated

Product Quantity: 61 units

Code Information:

Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931

Distribution Pattern:

US distribution to AZ, IA, IN, MA, and ND.

Voluntary or Mandated:

Voluntary: Firm initiated