Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation error (incorrect instructions for use) rather than a physical defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 518 Biliary Stent 5mm x 40mm (Catalog Number: ZIB5-125-5.0-40). The recall is due to an error in the instruction for use (IFU) document. Specifically, the details provided for removing the delivery system as part of the stent deployment process are incorrect.
The affected product is intended for the palliation of malignant neoplasms in the biliary tree. The recall covers units distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico. The Global Product Number (GPN) for the affected units is G31352.
The manufacturer is correcting the IFU to amend the incorrect instruction details. No specific consumer actions are detailed in the source text beyond the correction of the documentation.
The recalled product
- 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.
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Biliary Stent
- Hazard
- Affected units
- 9,834
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GPN: G31352
Distribution
Part of a larger recall action
This product is one of 39 recalled by Cook Medical Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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