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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 issue (incorrect instructions) with no reported injuries, illnesses, or functional defects in the device itself.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 635 Biliary Stent 5mm x 60mm (Catalog Number: ZIB6-80-5.0-60). 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 recall covers units distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico.
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 beyond the correction of the documentation.
The recalled product
- Product
- Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 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: G32009
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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