Cook Medical Recalls Zilver 518 Biliary Stents Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 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 source text identifies the issue as an incorrect instruction for use detail rather than a physical defect or reported injury, fitting the criteria for a moderate severity labeling/documentation error.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 518 Biliary Stent 4mm x 60mm (Catalog Number: ZIB5-125-4.0-60). 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 the affected product is G31441.
Healthcare providers and facilities should stop using the affected stents and contact Cook Medical Incorporated for further instructions on how to return or dispose of the product. Patients who have already received the stent should consult their healthcare provider if they have concerns about the procedure.
The recalled product
- Product
- Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 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: G31441
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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