Z-2791-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- May 31, 2018
- Termination Date
- April 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250
Product Description
VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
Reason for Recall
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
Distribution Pattern
One distributor in Indiana; product was not further distributed to end users.
Code Information
lot 8639185