VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Reported: December 23, 2015 Initiated: November 19, 2015 #Z-0416-2016
Product Description
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Reason for Recall
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 35
- Distribution
- Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.. Recalled by Cook Inc.. Units affected: 35.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2015. Severity: Moderate. Recall number: Z-0416-2016.
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