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U.S. Department of Health and Human Services

Class 1 Device Recall Fixed Core Wire Guide

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  Class 1 Device Recall Fixed Core Wire Guide see related information
Date Initiated by Firm October 22, 2020
Date Posted November 03, 2020
Recall Status1 Terminated 3 on September 02, 2021
Recall Number Z-0399-2021
Recall Event ID 86642
Product Classification Wire, guide, catheter - Product Code DQX
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.
Code Information Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customers Relations Department
800-457-4500
Manufacturer 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.
FDA Determined
Cause 2		 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 (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.
Quantity in Commerce 61 units
Distribution US distribution to AZ, IA, IN, MA, and ND.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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