Recall Z-0351-2019— Cook Medical Incorporated
Class II · Terminated
Class II FDA medical device recall by Cook Medical Incorporated, initiated 2018-09-25, terminated 2020-06-04. It names one FDA 510(k) clearance: K050698. Product: Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.. 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..
- Recalling firm
- Cook Medical Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-25
- Terminated
- 2020-06-04
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.