Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to incorrect documentation (IFU) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cook Medical Incorporated is voluntarily recalling 9,834 units of the Zilver 635 Biliary Stent 4mm x 80mm (Catalog Number: ZIB6-125-4.0-80). The recall was initiated because the instruction for use (IFU) contains incorrect details regarding the removal of the delivery system during the deployment of the stent. The manufacturer is correcting the IFU to amend these instructions.
The affected stents are intended for the palliation of malignant neoplasms in the biliary tree. The recall covers units distributed nationwide across all 50 states, the District of Columbia, and Puerto Rico. The General Product Number (GPN) for the affected units is G36021.
Healthcare providers and facilities should stop using the affected stents and contact Cook Medical Incorporated for further instructions on how to return or replace the product. Patients who have already received the device should consult their healthcare provider if they have questions regarding the recall.
The recalled product
- Product
- Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 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: G36021
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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