—#184234

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.

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 (FieldActionsNA@CookMedical.com). 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: CustomerRelationsNA@CookMedical.com.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: US distribution to AZ, IA, IN, MA, and ND.

Timeline

Recall initiated: 2020-10-22
Posted by FDA: 2020-11-03
Terminated: 2021-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184234. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.