Cook Medical Recalls Zilver 635 Biliary Stents 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
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to an incorrect instruction for use (documentation issue) with no reported injuries or illnesses, fitting the criteria for a Low severity score (documentation issues).
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 635 Biliary Stent 12mm x 30mm (Catalog Number: ZIB6-80-12.0-30). The recall is being conducted 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 devices were distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico. The Zilver 518 and 635 Biliary Stents are intended for the palliation of malignant neoplasms in the biliary tree.
The source text does not specify specific actions for consumers or healthcare providers beyond the correction of the IFU. No illnesses, injuries, or deaths are reported in the source text.
The recalled product
- Product
- Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 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: G36228
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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