| Class 2 Device Recall Zilver 518 Biliary Stent | |
Date Initiated by Firm | September 25, 2018 |
Create Date | October 31, 2018 |
Recall Status1 |
Terminated 3 on June 04, 2020 |
Recall Number | Z-0321-2019 |
Recall Event ID |
81238 |
510(K)Number | K050698 |
Product Classification |
Stents, drains and dilators for the biliary ducts - Product Code FGE
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Product | Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. |
Code Information |
GPN: G31352 |
Recalling Firm/ Manufacturer |
Cook Medical Incorporated 400 N Daniels Way Bloomington IN 47404-9155
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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 |
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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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510(K) Database | 510(K)s with Product Code = FGE
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