Cook Medical Recalls Zilver 635 Biliary Stent for 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a documentation error (incorrect IFU) rather than a physical defect or contamination, fitting the 'Moderate' criteria for minor labeling or documentation issues.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 635 Biliary Stent 5mm x 40mm (Catalog Number: ZIB6-80-5.0-40). The recall was initiated because the instruction for use (IFU) contains incorrect details regarding the removal of the delivery system as part of the stent deployment process. The IFU is being corrected 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 in the United States, including all 50 states, the District of Columbia, and Puerto Rico.
The Global Product Number (GPN) for this recall is G32008. No specific consumer actions are detailed in the provided source text beyond the correction of the IFU.
The recalled product
- Product
- Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 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: G32008
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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