Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain 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 source text identifies the hazard as an incorrect instruction for use (documentation issue) rather than a physical defect or reported injury. This aligns with the 'Moderate' criterion for minor labeling or documentation errors.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 635 Biliary Stent (14mm x 80mm, Catalog Number: ZIB6-80-14.0-80). The recall is due to an error in the instruction for use (IFU) document. Specifically, the details provided for the removal of the delivery system during the deployment of the stent are incorrect.
The affected stents are intended for the palliation of malignant neoplasms in the biliary tree. The product was 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 G36236.
The company is correcting the instruction for use to amend the incorrect details. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take with the device.
The recalled product
- Product
- Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 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: G36236
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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