VentriClear¿ II Ventricular Drainage Catheter Set. recall: Labeling Error
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Why was VentriClear¿ II Ventricular Drainage Catheter Set. recalled?
Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X
- Product
- VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
- Recalling firm
- Cook Inc.
- Quantity
- 35
- Distribution
- Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
- Recall date
- December 23, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)