Recall Z-0322-2019 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
| Date | Sep 25, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 Acknowledg |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050698 | MODIFICATION TO:ZILVER 518 BILIARY STENT Cook, Inc., Mar 30, 2005 |