Cook Inc.: Medical Device Recall in 2019 - (Recall #: Z-0589-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.

Product Classification:

Class I

Date Initiated: November 8, 2019

Date Posted: December 18, 2019

Recall Number: Z-0589-2020

Event ID: 84212

Reason for Recall:

A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).

Status: Terminated

Product Quantity: 43

Code Information:

Lot Numbers 9945301, 9953512 UDI: (01)00827002515833(17)221308(10)9945301 UDI: (01)00827002515833(17)221608(10)9953512

Distribution Pattern:

Distribution to US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil.

Voluntary or Mandated:

Voluntary: Firm initiated