Z-2791-2018 Class II Terminated
FDA device recall Z-2791-2018 was initiated by Cook Inc. on May 31, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 11, 2019). Affected quantity: 250.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 22, 2018
- Initiation Date
- May 31, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2791-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026