Z-0399-2021Class I

Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating...

Name: Z-0399-2021 Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating...
Creator: Cook Inc.
Published: 2020-10-22
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2020-10-22 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of 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... on 2020-10-22. FDA classified it as Class I and gives the reason as "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". 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-0399-2021
Classification: Class I
Status: Terminated
Initiated: 2020-10-22
Posted: 2020-11-03
Terminated: 2021-09-02
Recalling firm: Cook Incorporated
Product: 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 code: DQX Wire, Guide, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 22, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to take the following actions: 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. 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: 61 units
Distribution: US distribution to AZ, IA, IN, MA, and ND.
Product codes and lots: Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0399-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0399-2021	Class I	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-03

Product code DQX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)