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U.S. Department of Health and Human Services

Class 2 Device Recall Zilver 635 Biliary Stent

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  Class 2 Device Recall Zilver 635 Biliary Stent see related information
Date Initiated by Firm September 25, 2018
Create Date October 31, 2018
Recall Status1 Terminated 3 on June 04, 2020
Recall Number Z-0325-2019
Recall Event ID 81238
510(K)Number K043481  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
Product Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40


Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Code Information GPN: G36239
Recalling Firm/
Manufacturer		 Cook Medical Incorporated
400 N Daniels Way
Bloomington IN 47404-9155
For Additional Information Contact Cook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		 The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Correction notification letters dated 9/25/18 were distributed to customers. The letter identified affected product, problem and actions to be taken. Urgent Medical Device Correction notification letters dated 9/25/18 were distributed to customers. Customers were instructed to: 1. Examine your inventory immediately to determine if you have affected product(s). 2. Read the notice carefully and communicate the correction to users. 3. Maintain a copy of this notice for your own records. 4. Ensure users are aware of the IFU modifications. 5. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it. 6. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com. For questions contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.
Quantity in Commerce 9834 total
Distribution US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
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.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = COOK, INC.
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