Z-0589-2020Class I

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

Name: Z-0589-2020 CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and...
Creator: Cook Inc.
Published: 2019-11-08
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2019-11-08 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures on 2019-11-08. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0589-2020
Classification: Class I
Status: Terminated
Initiated: 2019-11-08
Posted: 2019-12-09
Terminated: 2021-02-01
Recalling firm: Cook Incorporated
Product: CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
Product code: KRA Catheter, Continuous Flush
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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].
Quantity in commerce: 43
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 codes and lots: Lot Numbers 9945301, 9953512 UDI: (01)00827002515833(17)221308(10)9945301 UDI: (01)00827002515833(17)221608(10)9953512

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0589-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0587-2020	Class I	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-09
Z-0588-2020	Class I	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-09
Z-0589-2020	Class I	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-09
Z-0590-2020	Class I	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-09

Product code KRA

K161801Class IICrossCath Support CatheterCook Incorporated / cleared 2016-07-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)