CrossCath recallZ-0588-2020 · Cook Inc. · initiated Nov 8, 2019

Why it was recalled

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).

FDA root cause category: Process control

What the company is doing

Urgent Medical Device Recall notification letters dated 11/8/19 were sent. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. Note: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected].

Recall details

Recall number

Z-0588-2020

Status

Terminated

Initiated by the company

Nov 8, 2019

Posted by the FDA

Dec 9, 2019

Recalling firm

Cook Inc.

Quantity

6

Product code

KRA

FDA submissions

K161801

Distribution

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.

Product description

CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• CrossCath G51575

  Cook Incorporated · Catheter, continuous flush
  1 recall0 reports

Product lines

• CrossCathCook Incorporated · 10 models · 31 reports · 4 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 84212).

• Z-0587-2020 · Terminated
  CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
• Z-0589-2020 · Terminated
  CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
• Z-0590-2020 · Terminated
  CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.